Mechanical methods for induction of labour

Marieke DT de Vaan; Mieke LG ten Eikelder; Marta Jozwiak; Kirsten R Palmer; Miranda Davies-Tuck; Kitty WM Bloemenkamp; Ben Willem J Mol; Michel Boulvain

doi:10.1002/14651858.CD001233.pub4

Mechanical methods for induction of labour

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Versión publicada: 30 marzo 2023 Historial de versiones

https://doi.org/10.1002/14651858.CD001233.pub4

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Abstract

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Background

Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012.

Objectives

To determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low‐dose misoprostol (oral and vaginal), amniotomy or oxytocin.

Search methods

For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review.

Selection criteria

Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods.

Mechanical methods include: (1) the introduction of a catheter through the cervix into the extra‐amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra‐amniotic space (EASI).

This review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone.

Data collection and analysis

Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.

Main results

This review includes a total of 112 trials, with 104 studies contributing data (22,055 women; 21 comparisons). Risk of bias of trials varied. Overall, the evidence was graded from very‐low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.

Balloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; low‐quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate‐quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate‐quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate‐quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low‐quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five‐minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively.

Balloon versus low‐dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low‐quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate‐quality evidence) but may increase the risk of a caesarean section (RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; low‐quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low‐quality evidence, and five‐minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low‐quality evidence.

Balloon versus low‐dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate‐quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low‐quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low‐quality evidence, five‐minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low‐quality evidence.

Authors' conclusions

Low‐ to moderate‐quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted.

Moderate‐quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low‐dose vaginal misoprostol, low‐quality evidence shows a balloon may be less effective, but probably has a better safety profile.

Future research could be focused more on safety aspects for the neonate and maternal satisfaction.

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

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Mechanical methods for induction of labour

We set out to determine from randomised controlled trials the effectiveness and safety of mechanical methods to bring on labour in the third trimester of pregnancy (> 24 weeks' gestation). Use of a balloon to stretch the cervix (the lower end of the uterus) was compared with prostaglandin E2 (PGE2), low‐dose misoprostol or oxytocin.

What is the issue?

Induction is carried out generally when the risk of continuing pregnancy outweighs the benefits, or at the request of pregnant women.

Mechanical methods for induction promote cervical ripening and onset of labour by stretching the cervix. They are amongst the oldest methods used to initiate labour. During the last decades, medication such as PGE2, misoprostol and oxytocin have partly replaced mechanical methods.

Why is this important?

More and more women have labour induced and indications are often not urgent. This means that the safety aspects of induction methods become more important, although this could be at the expense of effectiveness. Mechanical methods could have advantages over pharmacological methods as they are widely available, low in cost and may have fewer side effects, such as excessive contractions of the uterus (uterine hyperstimulation). This could potentially be safer for the baby because if contractions are too long or very close together, the baby may not receive sufficient oxygen.

What evidence did we find?

For this review we included a total of 112 randomised controlled trials involving 22,055 women who were scheduled for induction of labour for different indications. The data contributed to 21 different comparisons. Overall, the evidence was graded from very low to moderate quality. For many comparisons there were too few women in the trials to determine any clear differences in serious illness for mothers and babies.

Twenty‐eight trials (6619 women) showed mechanical induction with a balloon is as effective as vaginal PGE2 as there may be little or no difference in vaginal deliveries within 24 hours and there probably is little or no difference in caesarean sections between groups. However, a balloon appears to be safer for the neonate as it probably reduces the risk of uterine hyperstimulation with an abnormal heart rate of the baby, serious illness or death of the baby and may slightly reduce the risk for a neonatal intensive care unit admission. It was unclear if there was a difference in serious illness or death of the mother or in the five‐minute Apgar score less than seven.

Thirteen trials (1818 women) compared induction of labour with a balloon with vaginal misoprostol and showed a balloon probably reduces the risk of uterine hyperstimulation with an abnormal heart rate of the baby, but may increase the risk of a caesarean section. It was unclear if there was a difference in vaginal deliveries within 24 hours, serious illness or death of the baby, serious illness or death of the mother, five‐minute Apgar score less than seven or neonatal intensive care unit admissions.

Seven trials (3178 women) showed a balloon may be less effective than oral misoprostol as a balloon probably increases the risk of a vaginal delivery not achieved within 24 hours and probably slightly increases the risk of a caesarean section. Data on safety are still unclear as it is uncertain whether there is a difference in uterine hyperstimulation with an abnormal heart rate of the baby, serious illness or death of the baby, serious illness or death of the mother, five‐minute Apgar score less than seven or neonatal intensive care unit admissions.

What does this mean?

Mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile for the baby. More research on this comparison does not seem warranted.

A balloon catheter may be slightly less effective as oral misoprostol, but It remains unclear if there is a difference in safety outcomes for the baby. When compared to low‐dose vaginal misoprostol, a balloon catheter may be less effective, but probably has a better safety profile for the baby.

Future research could focus more on safety aspects for the baby and maternal satisfaction.

Authors' conclusions

Implications for practice

Mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2 with little or no difference in vaginal deliveries not achieved within 24 hours and caesarean section rate between the two methods. However, a balloon seems to have a more favourable safety profile compared to vaginal PGE2, as it probably reduces the risk of uterine hyperstimulation with and without fetal heart rate (FHR) changes, fetal distress for which a caesarean section is indicated and serious neonatal morbidity or perinatal death.

A balloon catheter may be less effective for induction of labour when compared to low‐dose oral misoprostol as a balloon probably increases the risk of a vaginal delivery not achieved within 24 hours and probably slightly increases the risk of a caesarean section. It is unclear if there is a difference in hyperstimulation with FHR changes. When compared to low‐dose vaginal misoprostol, a balloon catheter may increase the risk of a caesarean section but probably reduces the risk of hyperstimulation, with and without FHR change as well as the risk of meconium‐stained liquor.

Cervical ripening with a balloon seems to be more effective than induction with oxytocin as it probably reduces the risk of caesarean section and the risk of fetal distress. For women with a previous caesarean section, a balloon catheter may slightly reduce the risk of a caesarean section when compared to oxytocin.

There is no evidence of a benefit of a double balloon over a single balloon. For the comparisons of a laminaria tent or extra‐amniotic space infusion (EASI) with other induction methods, results were mostly too imprecise to make a valid judgement.

There was no evidence of clear benefit for a mechanical method combined with PGE2 to PGE2 alone or to oxytocin. When a mechanical method is combined with oxytocin, it may reduce the risk of neonatal intensive care unit (NICU) admissions when compared to misoprostol alone. However, regarding other perinatal outcomes for both comparisons, there was no evidence for a difference in serious neonatal morbidity or perinatal death, Apgar scores less than seven at five minutes or fetal distress. No evidence of a benefit of a mechanical method combined with misoprostol compared to misoprostol alone or to PGE2 was found.

The advantages of mechanical methods are their wide availability and the low cost of the devices, especially Foley catheters. Storage and preservation of mechanical devices is less problematic than PGE2, which should be kept refrigerated. However, special attention should be paid to contraindications (e.g. low‐lying placenta) when inserting these devices.

Implications for research

There seems to be sufficient data to make a valid judgement on the safety and effectiveness of balloon in comparison to vaginal PGE2. More research on this comparison does not seem warranted as moderate‐quality evidence suggests a balloon is equally effective, but has a better safety profile. GRADE assessment for important outcomes for this comparison can never be assessed as 'high quality' because blinding is not possible and this is the reason the evidence being downgraded from high‐quality evidence to moderate‐quality evidence for key outcomes. Future research could focus on comparing a balloon with low‐dose misoprostol or a combination of mechanical methods with low‐dose misoprostol. More studies evaluating mechanical methods for induction of labour in women with a history of prior caesarean section could be of benefit.

To facilitate future meta‐analyses of labour induction, we recommend the standardisation of outcomes through core outcome sets. This would minimise the reporting challenges experienced in this review, where many included studies reported outcomes in a highly varied manner, resulting in many being excluded from analyses. Also, while there were many large randomised trials included in this review, only a few reported on rare but serious adverse events or included women's views regarding induction methods. As safety aspects and maternal satisfaction become more and more important with rising induction rates, large multicentre studies focusing on safety aspects for the neonate and maternal satisfaction, could help clinicians make a more carefully balanced choice when arranging an induction of labour.

Summary of findings

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Summary of findings 1. Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus
Patient or population: third trimester labour induction in women with a viable fetus Setting: Australia, China, Denmark, Iran, Jordan, India, Italy, Israel, Nigeria, Pakistan, Singapore, Sweden, the Netherlands, USA, UK Intervention: balloon (Foley or ATAD) Comparison: vaginal prostaglandin E2
Outcomes	Risk with vaginal prostaglandin E2	Risk with balloon (Foley or ATAD)	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Vaginal delivery not achieved in 24 hours	Study population		RR 1.01 (0.82 to 1.26)	1685 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Vaginal delivery not achieved in 24 hours	528 per 1000	533 per 1000 (433 to 665)	RR 1.01 (0.82 to 1.26)	1685 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Uterine hyperstimulation with FHR changes	Study population		RR 0.35 (0.18 to 0.67)	1966 (6 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Uterine hyperstimulation with FHR changes	31 per 1000	11 per 1000 (6 to 21)	RR 0.35 (0.18 to 0.67)	1966 (6 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Caesarean section	Study population		RR 1.00 (0.92 to 1.09)	6619 (28 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Caesarean section	238 per 1000	238 per 1000 (219 to 260)	RR 1.00 (0.92 to 1.09)	6619 (28 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Serious neonatal morbidity or perinatal death	Study population		RR 0.48 (0.25 to 0.93)	2757 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Serious neonatal morbidity or perinatal death	20 per 1000	9 per 1000 (5 to 18)	RR 0.48 (0.25 to 0.93)	2757 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Serious maternal morbidity or death	Study population		RR 0.20 (0.01 to 4.12)	1481 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 3}
Serious maternal morbidity or death	3 per 1000	1 per 1000 (0 to 11)	RR 0.20 (0.01 to 4.12)	1481 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 3}
Apgar score < 7 at 5 minutes	Study population		RR 0.74 (0.49 to 1.14)	4271 (14 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
Apgar score < 7 at 5 minutes	22 per 1000	16 per 1000 (11 to 25)	RR 0.74 (0.49 to 1.14)	4271 (14 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
Neonatal intensive care unit admission	Study population		RR 0.82 (0.65 to 1.04)	3647 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
Neonatal intensive care unit admission	74 per 1000	60 per 1000 (48 to 77)	RR 0.82 (0.65 to 1.04)	3647 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event) ²We downgraded (1) level for serious inconsistency due to evidence of statistical heterogeneity (I² = >30%) ³We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events ⁴We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect

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Summary of findings 2. Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus
Patient or population: third trimester induction of labour in women with a viable fetus Setting: Brazil, Egypt, India, Iran, Nigeria, the Netherlands, Sweden Intervention: balloon (Foley or ATAD) Comparison: low‐dose vaginal misoprostol
Outcomes	Risk with low‐dose vaginal misoprostol	Risk with balloon (Foley or ATAD)	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Vaginal delivery not achieved in 24 hours	Study population		RR 1.09 (0.85 to 1.39)	340 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Vaginal delivery not achieved in 24 hours	412 per 1000	449 per 1000 (350 to 573)	RR 1.09 (0.85 to 1.39)	340 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Uterine hyperstimulation with FHR changes	Study population		RR 0.39 (0.18 to 0.85)	1322 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Uterine hyperstimulation with FHR changes	33 per 1000	13 per 1000 (6 to 28)	RR 0.39 (0.18 to 0.85)	1322 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Caesarean section	Study population		RR 1.28 (1.02 to 1.60)	1756 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 3}
Caesarean section	243 per 1000	311 per 1000 (247 to 388)	RR 1.28 (1.02 to 1.60)	1756 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 3}
Serious neonatal morbidity or perinatal death	Study population		RR 0.58 (0.12 to 2.66)	381 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 4}
Serious neonatal morbidity or perinatal death	21 per 1000	12 per 1000 (2 to 55)	RR 0.58 (0.12 to 2.66)	381 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 4}
Serious maternal morbidity or death	Study population		not estimable	464 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}	no events occurred in included studies
Serious maternal morbidity or death	0 per 1000	0 per 1000 (0 to 0)	not estimable	464 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}	no events occurred in included studies
Apgar score < 7 at 5 minutes	Study population		RR 1.00 (0.50 to 1.97)	941 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Apgar score < 7 at 5 minutes	30 per 1000	30 per 1000 (15 to 59)	RR 1.00 (0.50 to 1.97)	941 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Neonatal intensive care unit admission	Study population		RR 1.00 (0.61 to 1.63)	1302 (9 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 6}
Neonatal intensive care unit admission	47 per 1000	47 per 1000 (29 to 77)	RR 1.00 (0.61 to 1.63)	1302 (9 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 6}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event) ²We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect ³We downgraded (1) level for serious inconsistency due to evidence of statistical heterogeneity (I² = >30%) ⁴We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events ⁵ We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and no events reported in included studies ⁶ Although there was some evidence suggesting small‐study effect we did not downgrade for publication bias because individual studies did not reach statistical significance and there was low heterogeneity across all studies for this outcome. Also, no difference was found between fixed‐effect or random‐effect analyses

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Summary of findings 3. Balloon (Foley or ATAD) compared to low‐dose oral misoprostol for third trimester induction of labour in women with a viable fetus

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Balloon (Foley or ATAD) compared to low‐dose oral misoprostol for third trimester induction of labour in women with a viable fetus
Patient or population: third trimester induction of labour in women with a viable fetus Setting: Finland, India, Pakistan, Sri Lanka, the Netherlands Intervention: balloon (Foley or ATAD) Comparison: low‐dose oral misoprostol
Outcomes	Risk with low‐dose oral misoprostol	Risk with balloon (Foley or ATAD)	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Vaginal delivery not achieved within 24 hours	Study population		RR 1.28 (1.13 to 1.46)	782 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Vaginal delivery not achieved within 24 hours	476 per 1000	609 per 1000 (538 to 695)	RR 1.28 (1.13 to 1.46)	782 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Uterine hyperstimulation with FHR changes	Study population		RR 0.81 (0.48 to 1.38)	2033 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Uterine hyperstimulation with FHR changes	29 per 1000	24 per 1000 (14 to 40)	RR 0.81 (0.48 to 1.38)	2033 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Caesarean section	Study population		RR 1.17 (1.04 to 1.32)	3178 (7 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 3}
Caesarean section	222 per 1000	259 per 1000 (230 to 293)	RR 1.17 (1.04 to 1.32)	3178 (7 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 3}
Serious neonatal morbidity or perinatal death	Study population		RR 1.11 (0.60 to 2.06)	2627 (3 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Serious neonatal morbidity or perinatal death	14 per 1000	16 per 1000 (9 to 30)	RR 1.11 (0.60 to 2.06)	2627 (3 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Serious maternal morbidity or death	Study population		RR 0.50 (0.05 to 5.52)	2627 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}
Serious maternal morbidity or death	2 per 1000	1 per 1000 (0 to 8)	RR 0.50 (0.05 to 5.52)	2627 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}
Apgar score < 7 after 5 minutes	Study population		RR 0.71 (0.38 to 1.32)	2693 (4 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Apgar score < 7 after 5 minutes	18 per 1000	13 per 1000 (6 to 28)	RR 0.71 (0.38 to 1.32)	2693 (4 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Neonatal intensive care unit admission	Study population		RR 0.82 (0.58 to 1.17)	2873 (5 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Neonatal intensive care unit admission	46 per 1000	37 per 1000 (26 to 53)	RR 0.82 (0.58 to 1.17)	2873 (5 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event) ²We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect ³ Trial of Mundle 2017 did not meet the pre‐specified population as pregnancies with a non viable fetus were included. Sensitivity analyses did not alter the estimated effect size. Therefore we did not downgrade ⁴ Trial of Mundle 2017 did not meet the pre‐specified population as pregnancies with a non viable fetus were included. Sensitivity analysis did not change the direction of the effect size and numbers of events were not higher compared to other trials. Therefore we did not downgrade. ⁵ We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events

Background

The previous version of this review formed one of a series of reviews of methods for induction of labour that followed a standardised published ’generic’ protocol (Hofmeyr 2009). These reviews were initially developed to help inform the recommendations of the National Institute for Health and Care Excellence (NICE) clinical practice guidelines on induction of labour (NICE 2008). This review no longer strictly follows the original protocol and has been updated with the intention of being a stand‐alone review. This is an update of a review first published in 2001 (Boulvain 2001), and last updated in 2012 (Jozwiak 2012).

Description of the condition

Labour induction is a common obstetric procedure, which is generally carried out when the risk of continuing pregnancy outweighs the benefits. Also, induction of labour is being used more and more at the request of pregnant women to shorten the duration of pregnancy or to time the birth of the baby according to the convenience of the mother and/or healthcare workers (WHO 2011). In the USA, approximately one in four women are induced and in the last decade, the induction rate in the UK has risen up to almost 30% (NICE 2008; NHS 2017). Although rates are generally lower in developing countries, in some settings they can be as high as those observed in developed countries (WHO 2011). To maximise the success of induction of labour in women with an unfavourable cervix, various ripening methods are available.

Description of the intervention

Mechanical methods were the first methods developed to ripen the cervix and induce labour (Thiery 1989). Devices that were used in this context include various type of catheters and laminaria tents, introduced into the cervical canal or through the cervix into the extra‐amniotic space. During recent decades they were partly substituted by pharmacological methods, including various prostaglandin E2 (PGE2) preparations (vaginal gel, tablets, inserts, intracervical gel), prostaglandin E1 (PGE1; misoprostol tablets, applied either orally or vaginally) and oxytocin. Pharmacological methods however, have a variety of effects at different sites and receptors in the body that can lead to unwanted side effects when used, such as uterine hyperstimulation (excessive contractions of the uterus) and as result, fetal distress. Therefore, mechanical induction methods are gaining in popularity as it has the potential to have a better safety profile compared to pharmacological methods, however possibly at the cost of a longer duration of labour. These factors need to be considered to determine the most appropriate methods depending on the clinical situation, with impact on labour duration possibly being of secondary importance as more women have labour induced for less urgent indications.

How the intervention might work

The goal of mechanical induction methods is to ripen the cervix, which can be achieved directly through dilatation of the canal, indirectly by increasing prostaglandin or oxytocin secretion, or both (Keirse 1983). In addition to the local effect, mechanisms which involve neuro‐endocrine reflexes (the Ferguson reflex) may promote the onset of contractions, leading to labour onset (Krammer 1995b).

The standard Foley urinary catheter can be used, as well as a specially developed 'Atad' double‐balloon catheter (Atad 1996) or Cook balloon. The catheter is introduced through the cervical canal to reach the extra‐amniotic space. The balloon is then inflated to keep the catheter in place. Traction is applied to the catheter in some cases. Another method involving catheters consists of infusing saline solution or prostaglandins through a catheter inserted, via the cervical canal, in the extra‐amniotic space (EASI).

Laminaria tents, made from sterile sea‐weed or synthetic hydrophilic materials (e.g. Lamicel), are introduced into the cervical canal. These devices increase in diameter because of their hydrophilic properties. This achieves a gradual stretching of the cervix.

Digital stripping or sweeping of the membranes is evaluated in a different review (Boulvain 2005).

Why it is important to do this review

Mechanical methods were never completely abandoned, but were substituted by pharmacological methods in recent decades. However, as induction rates rise and indications are often less urgent, the safety aspects of induction methods become more important, although this could be at the expense of effectiveness. Apart for being widely available and low in cost, potential advantages of mechanical methods over pharmacological ones may include a reduction in side effects, such as uterine hyperstimulation, thereby having the potential to improve neonatal outcomes.

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Clinical trials, comparing mechanical methods for cervical ripening or labour induction with other induction methods. Quasi‐randomised controlled trials and trials only reported as abstract were eligible for inclusion. Cluster‐randomised trials are unlikely to be conducted in this area, however, if identified by a future search, they will be handled with appropriate methods.

Types of participants

Pregnant women due for third trimester induction of labour, carrying a viable fetus.

Predefined subgroup comparisons were: previous caesarean section or not, nulliparity or multiparity. Only those outcomes with data appear in the analyses tables.

Types of interventions

Different types of intervention have been considered as mechanical methods: (1) the introduction of a catheter (Foley single balloon, Atad/Cook double balloon or other type), through the cervix into the extra‐amniotic space, either with or without traction; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluids, usually saline water, in the extra‐amniotic space (EASI).

Mechanical methods were compared with other induction methods (i.e. vaginal PGE2, intracervical PGE2, intravenous oxytocin, amniotomy, vaginal and oral misoprostol). For this update, the comparison with placebo/no treatment was left out. When the protocol for reviews of induction methods was designed, it was relevant to know if cervical ripening before actual induction of labour (rupturing the membranes, and if needed, administer of oxytocin) was beneficial. Since we already know the advantages of cervical ripening in case of an unfavourable cervix, no future trials will be done to study the effect of cervical ripening with a mechanical method versus no ripening. Also, in the case of pharmacological methods, it is possible to perform a placebo‐controlled study, but with mechanical methods of labour, this is not possible. Studies which do make this comparison between mechanical induction and no treatment, explore other objectives rather than the ones relevant for his review (induction of labour versus expectant management to improve birth outcome). Therefore, the choice was made to depart from the original research protocol and leave out this pre‐specified comparison. For this update, we also chose only to include low‐dose misoprostol (defined as ≤ 50 mcg every ≥ 4 hours) as evidence suggests low‐dose misoprostol is superior to high‐dose misoprostol regarding safety outcomes and being equally effective (Alfirevic 2014; Hofmeyr 2010).

In addition, other comparisons were made: (1) a single balloon compared to a double balloon; (2) laminaria tent compared to other hygroscopic dilatators; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone. These comparisons were not pre‐specified in the generic protocol of induction of labour reviews (Hofmeyr 2009).

Types of outcome measures

We included all clinically relevant outcomes for trials of methods of cervical ripening/labour induction as had been pre‐specified by two authors of the generic protocol for labour induction reviews (Justus Hofmeyr and Zarko Alfirevic). We added six more outcomes to the list of the original protocol. Differences were settled by discussion.

Primary outcomes

Five primary outcomes were chosen as being most representative of the clinically important measures of effectiveness and complications. Subgroup comparisons were limited to the primary outcomes:

vaginal delivery not achieved within 24 hours (from start cervical ripening);
uterine hyperstimulation with fetal heart rate (FHR) changes;
caesarean section;
serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood);
serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia).

Perinatal and maternal morbidity and mortality are composite outcomes. This is not an ideal solution because some components are clearly less severe than others. It is possible for one intervention to cause more deaths but less severe morbidity. However, in the context of labour induction in mainly term pregnancies, this is unlikely. All these events are rare, and a modest change in their incidence will be easier to detect if composite outcomes are presented. The incidence of individual components were explored as secondary outcomes (see below).

Secondary outcomes

Secondary outcomes relate to measures of effectiveness, complications and satisfaction.

Measures of effectiveness:

cervix unfavourable/unchanged after 12 to 24 hours;
oxytocin augmentation.

Complications:

uterine hyperstimulation without FHR changes;
uterine rupture;
epidural analgesia;
instrumental vaginal delivery;
meconium‐stained liquor;
Apgar score less than seven at five minutes;
neonatal intensive care unit (NICU) admission;
neonatal encephalopathy;
perinatal death;
disability in childhood;
maternal side effects (all);
maternal nausea;
maternal vomiting;
maternal diarrhoea;
other maternal side effects;
postpartum haemorrhage (as defined by the trial authors);
serious maternal complications (e.g. intensive care unit admission, septicaemia but excluding uterine rupture);
maternal death.

Measures of satisfaction:

woman not satisfied;
caregiver not satisfied.

The terminology of uterine hyperstimulation is problematic (Curtis 1987). In the review, we use the term 'uterine hyperstimulation without FHR changes' to include uterine tachysystole (more than five contractions per 10 minutes for at least 20 minutes) and uterine hypersystole/hypertonus (a contraction lasting at least two minutes) and 'uterine hyperstimulation with FHR changes' to denote uterine hyperstimulation syndrome (tachysystole or hypersystole with FHR changes such as persistent decelerations, tachycardia or decreased short‐term variability).

Search methods for identification of studies

The following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth.

Electronic searches

For this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register by contacting their Information Specialist (9 January 2018). We updated this search on 19 March 2019 and added the results to Studies awaiting classification for consideration in the next update.

The Register is a database containing over 25,000 reports of controlled trials in the field of pregnancy and childbirth. It represents over 30 years of searching. For full current search methods used to populate Pregnancy and Childbirth’s Trials Register including the detailed search strategies for CENTRAL, MEDLINE, Embase and CINAHL; the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service, please follow this link.

Briefly, Cochrane Pregnancy and Childbirth’s Trials Register is maintained by their Information Specialist and contains trials identified from:

monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);
weekly searches of MEDLINE (Ovid);
weekly searches of Embase (Ovid);
monthly searches of CINAHL (EBSCO);
handsearches of 30 journals and the proceedings of major conferences;
weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Search results are screened by two people and the full text of all relevant trial reports identified through the searching activities described above is reviewed. Based on the intervention described, each trial report is assigned a number that corresponds to a specific Pregnancy and Childbirth review topic (or topics) and is then added to the Register. The Information Specialist searches the Register for each review using this topic number rather than keywords. This results in a more specific search set that has been fully accounted for in the relevant review sections (Included, Excluded, Awaiting Classification or Ongoing).

In addition, we searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for unpublished, planned and ongoing trial reports (19 March 2019) using the search methods detailed in Appendix 1.

Searching other resources

We searched the reference lists of retrieved studies.

We did not apply any language or date restrictions.

Data collection and analysis

For methods used in the previous version of this review, seeJozwiak 2012.

For this update, the following methods were used for assessing the 247 reports that were identified as a result of the updated search. The following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth.

Selection of studies

Two review authors (Marieke de Vaan and Mieke ten Eikelder) independently assessed all potential studies identified as a result of the search strategy for inclusion. Any disagreement was resolved through discussion, or if required, by involving a third review author (Marta Jozwiak).

Data extraction and management

We designed a form to extract data. For eligible studies, two groups of two review authors (Marieke de Vaan, Marta Jozwiak, Ben Willem Mol and Kirsten Palmer) extracted the data using the agreed form. We resolved discrepancies through discussion or, if required, we consulted a third review author. Data were entered into Review Manager software (RevMan 2014) and checked by a second review author for accuracy.

When information regarding any of the above was unclear, we contacted authors of the original reports to provide further details.

Assessment of risk of bias in included studies

Two review authors (Marieke de Vaan and Mieke ten Eikelder) independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Any disagreement was resolved by discussion or by involving a third assessor (Marta Jozwiak).

(1) Random sequence generation (checking for possible selection bias)

We described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We assessed the method as:

low risk of bias (any truly random process, e.g. random number table; computer random number generator);
high risk of bias (any non‐random process, e.g. odd or even date of birth; hospital or clinic record number);
unclear risk of bias.

(2) Allocation concealment (checking for possible selection bias)

We described for each included study the method used to conceal allocation to interventions prior to assignment and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed the methods as:

low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
high risk of bias (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);
unclear risk of bias.

(3.1) Blinding of participants and personnel (checking for possible performance bias)

We described for each included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the methods as:

low, high or unclear risk of bias for participants;
low, high or unclear risk of bias for personnel.

(3.2) Blinding of outcome assessment (checking for possible detection bias)

We described for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as:

low, high or unclear risk of bias.

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

We described for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported, or could be supplied by the trial authors, we planned to re‐include missing data in the analyses which we undertook.

We assessed methods as:

low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);
high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial departure of intervention received from that assigned at randomisation);
unclear risk of bias.

(5) Selective reporting (checking for reporting bias)

We described for each included study how we investigated the possibility of selective outcome reporting bias and what we found.

We assessed the methods as:

low risk of bias (where it is clear that all of the study’s pre‐specified outcomes and all expected outcomes of interest to the review have been reported);
high risk of bias (where not all the study’s pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);
unclear risk of bias.

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

We described for each included study any important concerns we had about other possible sources of bias.

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented results as summary risk ratio with 95% confidence intervals.

Continuous data

No continuous data were analysed in this update. If outcomes using continuous data are included in future versions of this review, we will use the mean difference if outcomes are measured in the same way between trials. We will use the standardised mean difference to combine trials that measure the same outcome but use different methods.

Unit of analysis issues

Cluster‐randomised trials

Cluster‐randomised trials are eligible for inclusion in the analyses along with individually‐randomised trials. None have currently been identified. If in the future such trials are identified, we will adjust their standard errors using the methods described in the Handbook (Higgins 2011) using an estimate of the intracluster correlation co‐efficient (ICC) derived from the trial (if possible), from a similar trial or from a study of a similar population. If we use ICCs from other sources, we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster‐randomised trials and individually‐randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely.

We will also acknowledge heterogeneity in the randomisation unit and perform a sensitivity analysis to investigate the effects of the randomisation unit.

Cross‐over trials

Cross‐over trials were not eligible for inclusion.

Other unit of analysis issues

Trials in pregnancy and childbirth may include outcomes for multiple pregnancies, but the trials identified to date have included singleton pregnancies only. Trials with multiple pregnancy will be included, but the outcomes relating to the babies will have to take account of clustering of events, as outlined in the Pregnancy and Childbirth Group Methodological Guidelines and the Handbook (Higgins 2011).

Some trials are multi‐arm studies, where this occurs only the intervention arms relevant to this review were included and this is noted in the Characteristics of included studies table.

Dealing with missing data

For included studies, levels of attrition were noted. In future updates, if more eligible studies are included, we will explore the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis.

For all outcomes, analyses were carried out, as far as possible, on an intention‐to‐treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta‐analysis using the Tau², I² and Chi² statistics. We regarded heterogeneity as substantial if an I² was greater than 30% and either a Tau² was greater than zero, or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. In the case of substantial heterogeneity (above 30%), if possible, we explored it by subgroup analyses.

Assessment of reporting biases

When there were 10 or more studies in the meta‐analysis, we investigated reporting biases (such as publication bias) using funnel plots. We assessed funnel plot asymmetry visually. If asymmetry was suggested by a visual assessment, we performed exploratory analyses to investigate it.

Data synthesis

We carried out statistical analysis using the Review Manager software (RevMan 2014). We used fixed‐effect meta‐analysis for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect: i.e. where trials were examining the same intervention, and the trials’ populations and methods were judged sufficiently similar.

If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we used random‐effects meta‐analysis to produce an overall summary, if an average treatment effect across trials was considered clinically meaningful. The random‐effects summary was treated as the average range of possible treatment effects and the clinical implications of treatment effects differing between trials is discussed. If the average treatment effect was not clinically meaningful, we did not combine trials. When random‐effects analyses were used, the results were presented as the average treatment effect with 95% confidence intervals, and the estimates of Tau² and I².

Subgroup analysis and investigation of heterogeneity

We did not carry out formal subgroup analysis to investigate heterogeneity, but carried out additional analyses of subgroups of trials based on the following.

Previous caesarean section or not
Nulliparity or multiparity

The following outcomes were used in the subgroups.

Vaginal delivery not achieved within 24 hours
Uterine hyperstimulation with FHR changes
Caesarean section
Serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood)
Serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia)

Sensitivity analysis

We carried out sensitivity analyses to explore the effect of trial quality assessed by concealment of allocation, high attrition rates, or both, with poor quality studies being excluded from the analyses in order to assess whether this made any difference to the overall result.

Summary of findings and assessment of the certainty of the evidence

For this update, the quality of the evidence was assessed for the comparisons relating to the most frequently used methods of cervical ripening (i.e. vaginal prostaglandin E2 (PGE2), vaginal misoprostol, and oral misoprostol) using the GRADE approach as outlined in the GRADE handbook in order to assess the quality of the body of evidence relating to the following outcomes.

Vaginal delivery not achieved within 24 hours
Uterine hyperstimulation with FHR changes
Caesarean section
Serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood)
Serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia)
Neonatal intensive care unit admission
Apgar score less than seven at five minutes

For the main comparisons we used GRADEpro Guideline Development Tool to import data from Review Manager 5.3 (RevMan 2014) in order to create ’Summary of findings’ tables. A summary of the intervention effect and a measure of quality for each of the above outcomes was produced using the GRADE approach. The GRADE approach uses five considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates or potential publication bias.

Results

Description of studies

Results of the search

See: Figure 1.

Figure 1

Study flow diagram.

For this update, we identified 418 trial reports to assess in the search of 9 January 2018. One study (Pineda Rivas 2016) was retrieved through other sources. When exploring the included trial registration of this study, we found out that an abstract of this study was published.

We also reassessed the 17 reports awaiting classification and the four ongoing studies in the previous version of the review (Jozwiak 2012). One hundred and seventy‐one reports were screened out because they did not meet the scope for this review or were not randomised controlled trials. We then assessed trial reports which related to 166 new trials (247 reports). We included 59 new trials (118 reports), added two trial reports to already included studies and excluded 74 trials (102 reports). Two trials from the January 2018 search are awaiting classification (Agboghoroma 2015; Mallah 2011), and 21 are ongoing (Argilagos 2016; Beckmann 2013; Bekele 2017; Berndl 2016; Bhide 2017; Eser 2016; Goli 2017; Goonewardene 2016; Gupta 2016; Hassanzadeh 2017; Igwe 2017; Lacarin 2017; Lauterbach 2017; Levy 2016; Osoti 2016; Park 2012; Perrotin 2016; Tagore 2015; Viteri 2015; Wise 2016; Yildirim 2017).

Of the 71 previous included studies, we excluded 18 trials because they were no longer within the scope of this review. Four studies were excluded because they compared a mechanical method with a placebo or no cervical ripening (De Oliveira 2003; Gilson 1996; Gower 1982; Lackritz 1979), 11 studies because of the use of high‐dose misoprostol (Adeniji 2005b; Barrilleaux 2002a; Buccellato 2000; Chung 2003; Greybush 2001; Hill 2009; Kashanian 2006; Owolabi 2005; Rust 2001; Sciscione 2001; Vengalil 1998), two studies compared extra‐amniotic space infusion (EASI) versus induction with a balloon or laminaria (El‐El‐Torkey 1995; Lin 1995), and one study compared a balloon versus prostaglandin F2alpha (Mawire 1999).

In the updated search of 19 March 2019, we identified an additional 38 trial reports which were added to Studies awaiting classification for consideration in the next update. The references have been assessed but not incorporated into the review. Only seven of these trials are likely to contribute data for this review and are mainly small trials (Khatib 2019; Lim 2018; Osoti 2018; Souizi 2018; ten Eikelder 2017; Tulek 2018; Viteri 2019). We imputed the data for these trials and this resulted in no changes in terms of the direction or strength of the evidence. We will incorporate these studies fully at the next update.

March 2022: One included study has subsequently been retracted by the journal (Husain 2017) (identified by Cochrane Pregnancy and Childbirth's ongoing surveillance). This study has now been excluded

Included studies

Altogether, this review now comprises 112 included studies, 104 of which contributed data. The studies that contributed data involved 22,055 women (see Characteristics of included studies). Trials with more than two arms may be included in more than one comparison. No cluster‐randomised trials were identified by the search.

Eight studies did not contribute any data to this review because the outcomes of interest were not reported, or reported in a format that could not be included in this review (Biron‐Shental 2004; Deo 2013; Hughes 2002; Jalilian 2011; Peedicayil 1998; Qamar 2012; Thiery 1981; Zahoor 2014). These studies are therefore not included in the descriptions of study details and 'Risk of bias' assessment below.

Design

All included studies were randomised controlled trials although the randomisation method was not always well described and in three studies the allocation process was not truly random (Jagani 1982; Kandil 2012; Roztocil 1998). All studies involved two trial arms except for Aduloju 2016, Allouche 1993, Atad 1996, Browne 2011, Cromi 2011, Deo 2012, Dionne 2011, El Khouly 2017, Guinn 2000, Matonhodze 2003, Lewis 1983, Orhue 1995, Pennell 2009, Prager 2008, Saleem 2006, Sheikher 2009 and Yuen 1996, which had three arms. Gelisen 2005, Lyndrup 1989 and Roberts 1986 had four arms, and Jagani 1982 had five arms. Not all comparisons in these studies were relevant for this review and therefore one or more arms in the studies of Gelisen 2005, Jagani 1982, Lewis 1983 and Roberts 1986 were excluded.

Setting

Nine studies were multicentre studies (Edwards 2014c; Guinn 2000; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Lokkegaard 2015; Mundle 2017; Sarreau 2016; ten Eikelder 2016), the remaining studies were single‐centre studies.

All studies took place in a hospital setting, except for Henry 2013, in which the period of cervical ripening took place in an outpatient setting.

The included studies were conducted in the following countries: Australia (Henry 2013; Pennell 2009), Brazil (Filho 2002; Oliveira 2010, Canada (Lemyre 2006; Pineda Rivas 2016; St Onge 1995), Czech Republic (Roztocil 1998), China (Wang 2012; Wang 2014; Wu 2017; Yuen 1996), Denmark (Lokkegaard 2015; Lyndrup 1989; Lyndrup 1994), Egypt (Ahmed 2016; El Khouly 2017; Kandil 2012), Finland (Kruit 2016), France (Allouche 1993; Sarreau 2016;), India (Chavakula 2015; Dalui 2005; Deo 2012; Deshmukh 2011; Goonewardene 2014; Gunawardena 2012; Joshi 2016; Kuppulakshmi 2016; Laddad 2013; Lanka 2014; Meetei 2015; Mundle 2017; Sheikher 2009), Iran (Moini 2003; Niromanesh 2003; Roudsari 2011; Sharami 2005) Italy (Cromi 2011; Cromi 2012), Israel (Atad 1996; Barda 2018; Ophir 1992; Shechter‐Maor 2015; Salim 2011; Solt 2009), Jordan (Al‐Taani 2004; Khamaiseh 2012), the Netherlands (Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; ten Eikelder 2016), Nigeria (Aduloju 2016; Garba 2016; Orhue 1995; Tabowei 2003), Norway (Haugland 2012), Pakistan (Matonhodze 2003; Mazhar 2003; Saleem 2006), Russia (Glagoleva 1999), Rwanda (Gilson 2017), South Africa (Bagratee 1990; Jeeva 1982; Ntsaluba 1997), Singapore (Chua 1997), Sri Lanka (Rudra 2012; Somirathne 2017; Tan 2015), Sweden (Hemlin 1998; Prager 2008), Tunis (Benzineb 1996), Turkey (Gelisen 2005), the UK (Dionne 2011; Guinn 2000; Hay 1995; Johnson 1985; Lewis 1983), the USA (Al‐Ibraheemi 2018; Amorosa 2017; Blumenthal 1990; Browne 2011; Carbone 2013; Casey 1995; Culver 2004; Edwards 2014c; Hibbard 1998; Hoppe 2016; Hudon 1999; Jagani 1982; Krammer 1995a; Mackeen 2018; Mullin 2002; Perry 1998; Ridgway 1991; Roberts 1986; Rouben 1993; Sanchez‐Ramos 1992; Sciscione 1999; Suffecool 2014; Sullivan 1996; Tita 2006; Turnquest 1997).

Dates

The study of Blumenthal 1990 and Sanchez‐Ramos 1992 took place between 1980 and 1989; the studies of Allouche 1993, Guinn 2000, Hemlin 1998, Hibbard 1998, Khamaiseh 2012, Lyndrup 1994, Orhue 1995, Perry 1998, Roudsari 2011, Roztocil 1998, Sciscione 1999, St Onge 1995, Sullivan 1996 and Turnquest 1997 between 1990 and 1999; the studies of Tabowei 2003, Culver 2004 and Mullin 2002 between 1998 and 2001; the studies of Al‐Taani 2004, Cromi 2011, Deshmukh 2011, Dionne 2011, Filho 2002, Joshi 2016, Jozwiak 2012, Jozwiak 2013, Krammer 1995a, Lokkegaard 2015, Matonhodze 2003, Mazhar 2003, Moini 2003, Niromanesh 2003, Oliveira 2010, Pennell 2009, Prager 2008, Roudsari 2011, Rudra 2012, Saleem 2006, Sharami 2005 and Tita 2006 between 2000 and 2009; the studies of Jozwiak 2014 and Salim 2011 between 2008 and 2011; and the studies of Aduloju 2016, Ahmed 2016, Al‐Ibraheemi 2018, Amorosa 2017, Barda 2018, Browne 2011, Carbone 2013, Chavakula 2015, Cromi 2012, Edwards 2014c, El Khouly 2017, Garba 2016, Goonewardene 2014, Haugland 2012, Henry 2013, Hoppe 2016, Kandil 2012, Kruit 2016, Kuppulakshmi 2016, Laddad 2013, Mundle 2017, Noor 2015, Sarreau 2016, Somirathne 2017, Suffecool 2014, ten Eikelder 2016, Wang 2014 and Wu 2017 between 2010 and the present day.

For the remaining studies, no study period was reported (Atad 1996; Bagratee 1990; Benzineb 1996; Casey 1995; Chua 1997; Dalui 2005; Deo 2012; Gelisen 2005; Gilson 2017; Glagoleva 1999; Gunawardena 2012; Hay 1995; Hudon 1999; Jagani 1982; Jeeva 1982; Johnson 1985; Lanka 2014; Lanka 2014; Lewis 1983; Lyndrup 1989; Ntsaluba 1997; Ophir 1992; Pineda Rivas 2016; Ridgway 1991; Roberts 1986; Rouben 1993; Solt 2009; Shechter‐Maor 2015; Sheikher 2009; Tan 2015; Wang 2012; Yuen 1996).

Participants

Most studies included both nulliparous and multiparous women. Nine studies included only nulliparous women (Culver 2004; Deshmukh 2011; Gunawardena 2012; Johnson 1985; Kandil 2012; Pennell 2009; Sharami 2005; Suffecool 2014; Wang 2012) and two studies included only multiparous women (Al‐Taani 2004; Garba 2016).

Thirteen studies included women with a specific indication for labour induction or specific patient groups, i.e. women with a hypertensive disease (Mundle 2017), women with a body mass index (BMI) greater than 30 (Pineda Rivas 2016), post‐date pregnancies (Gelisen 2005; Goonewardene 2014; Gunawardena 2012; Kandil 2012; Somirathne 2017), oligohydramnios (Shechter‐Maor 2015; Wang 2014) or pre labour rupture of membranes (PROM; Amorosa 2017; Kruit 2016; Mackeen 2018; Tita 2006). Most authors specified that only women with intact membranes were included, except for Prager 2008, in which this was not an exclusion criteria. Orhue 1995, Roudsari 2011 and Roztocil 1998 reported nothing on membrane status, so it was not clear if women with ruptured membranes could be included.

Most studies excluded women with a past history of caesarean section, although four studies only included women with a past history of caesarean section (Joshi 2016; Meetei 2015; Sarreau 2016; Tabowei 2003). Three studies did not exclude women with a past history of caesarean section, but did not specify the outcomes for this subgroup of women separately (Mackeen 2018; Tabowei 2003; Tita 2006). Benzineb 1996, Cromi 2011, Deo 2012, Guinn 2000, Haugland 2012, Lyndrup 1994, Pineda Rivas 2016, Rouben 1993, and Wu 2017 reported nothing on previous caesarean section in their inclusion and exclusion criteria.

The majority of studies included women with a gestational age beyond 37 weeks, except for Edwards 2014c and Hemlin 1998 who reported a minimal gestational age of 36 weeks, Amorosa 2017, Chavakula 2015, Cromi 2011, Cromi 2012, Mackeen 2018 Matonhodze 2003, Pennell 2009; Roudsari 2011 and Sharami 2005 of 34 weeks, Dalui 2005 of 33 weeks, Lokkegaard 2015 of 32 weeks, Culver 2004, Lanka 2014 and El Khouly 2017 of 28 weeks, Browne 2011 of 26 weeks, Carbone 2013 of 24 weeks and Mundle 2017 of 20 weeks, although in this last study, no women with a gestational age below 28 weeks were included.

Twenty‐four studies were not clear on their inclusion and exclusion criteria: Gilson 2017, Jeeva 1982 and Kuppulakshmi 2016 reported no inclusion or exclusion criteria. Jagani 1982, Rudra 2012 and Turnquest 1997 only reported that women with intact membranes were included. Glagoleva 1999 only reported that women with a previous caesarean section were excluded. Bagratee 1990, Dionne 2011, Johnson 1985, Lyndrup 1989, Ridgway 1991, Solt 2009; Sullivan 1996 reported that only women with an indication for labour induction with an unfavourable cervix were included. Hemlin 1998 reported nothing on membrane status or previous caesarean section. Casey 1995, Garba 2016, Hudon 1999, Krammer 1995a, Lemyre 2006, Lewis 1983 and Saleem 2006 reported nothing on fetal presentation, membrane status or previous caesarean section. Chua 1997 and Ophir 1992 reported nothing on gestational age, fetal presentation, membrane status or previous caesarean section.

Interventions and comparisons

The protocol of administration in the intervention and in the control groups varied between studies. Different mechanical devices were evaluated (i.e. balloon catheter, laminaria tents, and extra‐amniotic infusion). Prostaglandins (intracervical or intravaginal PGE2, and oral or vaginal misoprostol) were used with different protocols of administration. We regrouped these protocols as follows: (1) balloon catheter versus other interventions; (2) laminaria tent versus other interventions: (3) extra‐amniotic infusion versus other interventions; (4) any mechanical method combined with other (non‐mechanical) intervention versus other interventions. For this last group of comparisons, we considered both PGE2 (intracervical or intravaginal PGE2) and misoprostol (oral or vaginal misoprostol) as a single intervention. The information on comparisons made in each trial, used device and balloon size is summarised below.

Studies evaluating laminaria or Dilapan were considered together, irrespective of the number of devices inserted. Similarly, evaluations of a Foley catheter (regardless of sizes and amount of liquid used to inflate the balloon and traction applied on the catheter) and a specially designed double‐balloon catheter (ATAD or Cook catheter), we considered as similar interventions. However, when a catheter was used to perform extra‐amniotic saline infusion (EASI), we considered these studies separately. Despite having regrouped similar interventions, this review still includes a large number of comparisons.

Most of the studies included in the review examined a balloon and compared it with either vaginal PGE2 or with vaginal or oral misoprostol. A smaller number of studies examined a balloon versus either intracervical PGE2 or oxytocin. Since the last update, no more studies have been published about induction of labour with a Laminaria tent or with EASI. None of the included studies examined the combination of a mechanical method with amniotomy.

The following comparisons were made in this review.

1. Balloon comparisons

Balloon (Foley or ATAD) versus vaginal prostaglandin E2

PGE2 tablets: Al‐Taani 2004 (50 cc); Atad 1996 (double balloon); Barda 2018 (80 cc); Khamaiseh 2012 (50 cc to 60 cc); Lokkegaard 2015 (double balloon); Niromanesh 2003 (30 cc); Ophir 1992 (40 cc); Pennell 2009 (30 cc and double balloon); Tan 2015 (double balloon).

PGE2 gel: Browne 2011 (40 cc); Deo 2012 (30 cc); Deshmukh 2011 (balloon size unknown); Henry 2013 (30 cc); Jozwiak 2012 (30 cc); Orhue 1995 (30 cc); Prager 2008 (30 cc); Rouben 1993 (30 cc); Rudra 2012 (40 cc).

PGE2 vaginal insert:Cromi 2011 (50 cc; for this comparison the two groups of Foley catheter (12 hours and 24 hours) were combined); Cromi 2012 (double balloon); Edwards 2014c (30 cc); Jozwiak 2013 (30 cc); Lewis 1983 (30 cc); Lyndrup 1994 (30 cc); Pineda Rivas 2016 (balloon size unknown); Saleem 2006 (40 cc to 50cc); Shechter‐Maor 2015 (double balloon); Suffecool 2014 (double balloon); Wang 2012 (80 cc); Wang 2014 (double balloon); Yuen 1996 (double balloon).

Balloon (Foley or ATAD) versus intracervical prostaglandin E2

PGE2 intracervical gel:Allouche 1993 (50 cc); gel: Benzineb 1996 (40 cc); Dalui 2005 (30 cc); Gunawardena 2012 (balloon size unknown); Hudon 1999 (40 cc); Kuppulakshmi 2016 (30 cc); Laddad 2013: (balloon size unknown); Moini 2003 (30 cc); Ntsaluba 1997 (30 cc); Sciscione 1999 (30 cc); St Onge 1995 (30 cc); Yuen 1996 (double balloon).

Balloon (Foley or ATAD) versus low‐dose vaginal misoprostol

Misoprostol tablets: Aduloju 2016 (30 cc); Chavakula 2015 (30 cc); Filho 2002 (30 cc); Jozwiak 2014 (30 cc); Kandil 2012 (30 cc); Lemyre 2006 (balloon size unknown); Noor 2015 (50 cc); Oliveira 2010 (30 cc); Prager 2008 (30 cc); Roudsari 2011 (50 cc); Sheikher 2009 (30 cc); Tabowei 2003 (50 cc).

Balloon (Foley or ATAD) versus low‐dose oral misoprostol

Misoprostol tablets:Goonewardene 2014 (balloon size unknown); Kruit 2016 (50 cc to 60 cc); Mundle 2017 (30 cc); Saleem 2006 (40 cc to 50 cc); Sheikher 2009 (30 cc); Somirathne 2017 (60 cc);ten Eikelder 2016 (30 cc). misoprostol solution:Matonhodze 2003 (50 cc).

Balloon (Foley or ATAD) versus oxytocin

Amorosa 2017 (60 cc); Atad 1996 (double balloon); El Khouly 2017 (30 cc); Gelisen 2005 (50 cc); Jagani 1982 (70 to 80 cc); Joshi 2016; (30 cc); Meetei 2015 (30 cc); Orhue 1995 (30 cc); Sarreau 2016 (50 cc).

Balloon (Foley or ATAD) versus amniotomy

Jagani 1982 (70 cc to 80 cc).

Single balloon (Foley versus double balloon (ATAD)

Ahmed 2016 (50 cc); Haugland 2012 (size unknown); Hoppe 2016 (30 cc); Pennell 2009 (30 cc); Salim 2011 (60 cc); Solt 2009 (balloon size unknown).

No studies were found for the comparison of a balloon versus oxytocin with amniotomy.

2. Laminaria comparisons

Laminaria tent versus vaginal prostaglandin E2

PGE2 tablets:Bagratee 1990 (Lamicel); Hay 1995 (Dilapan); Jeeva 1982; (laminaria).

PGE2 gel:Johnson 1985 (Lamicel); Roudsari 2011 (Dilapan); Sanchez‐Ramos 1992 (Dilapan).

Laminaria tent versus intracervical prostaglandin E2

PGE2 intracervical gel:Chua 1997 (Dilapan); Glagoleva 1999 (Dilapan); Krammer 1995a; (Dilapan); Roztocil 1998 (Dilapan).

Laminaria tent versus oxytocin

Jagani 1982 (70 to 80 cc); Roberts 1986 (Lamicel).

Laminaria tent versus amniotomy

Jagani 1982 (70 to 80 cc).

Laminaria tent versus other hygroscopic dilator

Blumenthal 1990 (Dilapan versus laminaria tent).

No studies were found for the comparison of laminaria tent versus oxytocin with amniotomy or laminaria tent versus vaginal or oral misoprostol.

3. EASI comparisons

The only studies which were found compared EASI with PGE2.

EASI versus vaginal prostaglandin E2

Vaginal insert:Mazhar 2003.

EASI versus intracervical prostaglandin E2

Intracervical gel:Hemlin 1998.

4. Any mechanical combined with prostaglandin E2 comparisons

Any mechanical method combined with prostaglandin E2 versus prostaglandin E2 alone

PGE2 intracervical gel:Allouche 1993 (50 cc); Casey 1995 (50 cc); Ridgway 1991 (Lamicel); Sullivan 1996 (50 cc).

PGE2 vaginal gel:Browne 2011 (40 cc); Hibbard 1998 (Dilapan); Lyndrup 1989; (Lamicel); Turnquest 1997 (Laminaria)

Any mechanical method combined with prostaglandin E2 versus low‐dose misoprostol alone

Vaginal misoprostol:Perry 1998.

Any mechanical method combined with prostaglandin E2 versus oxytocin alone

Lyndrup 1989 (Lamicel).

No studies were found which compared a mechanical method combined with PGE2 with amniotomy or oxytocin with amniotomy

5. Any mechanical combined with low‐dose misoprostol comparisons

Any mechanical method combined with low‐dose misoprostol versus prostaglandin E2 alone

Oral misoprostol:Matonhodze 2003.

Any mechanical method combined with low‐dose misoprostol versus low‐dose misoprostol alone

Vaginal misoprostol:Aduloju 2016 (30 cc); Al‐Ibraheemi 2018 (60 cc); Carbone 2013 (60 cc); Dionne 2011 (balloon size and dosage of misoprostol unknown); Lanka 2014 (30 cc).

Oral misoprostol:Matonhodze 2003 (50 cc).

No studies were found which compared a mechanical method combined with low‐dose misoprostol with amniotomy, oxytocin or oxytocin with amniotomy.

6. Any mechanical method combined with oxytocin comparisons

Any mechanical method combined with oxytocin versus prostaglandin E2 alone

PGE2 intracervical gel:Guinn 2000 (laminaria + oxytocin and EASI + oxytocin); Lyndrup 1989 (Lamicel); Sharami 2005 (EASI).

Any mechanical method combined with oxytocin versus low‐dose misoprostol alone

Vaginal misoprostol:Culver 2004 (30 cc); Dionne 2011 (balloon size unknown); Gilson 2017 (30 cc); Garba 2016 (balloon size and dosage of misoprostol unknown); Mullin 2002.

Any mechanical method combined with oxytocin versus oxytocin alone

El Khouly 2017 (30 cc); Lyndrup 1989 (Lamicel); Mackeen 2018 (30 cc); Tita 2006 (balloon size unknown); Wu 2017 (double balloon).

No studies were found which compared a mechanical method combined with oxytocin to amniotomy or oxytocin with amniotomy.

Outcomes

The study authors frequently reported on continuous outcome measures such as change in the cervical status or time to onset of labour, but also mean Apgar score after five minutes and mean pH in the umbilical artery. As these were not pre‐specified in our protocol, we have not included these results in the review. In several studies, the only pre‐specified result available was the number of women delivered by caesarean section. Maternal or neonatal death were infrequently pre‐specified by the authors and therefore not specifically reported. Therefore, these outcomes could not be included in this review.

Maternal satisfaction was reported in seven studies (Ahmed 2016; Chavakula 2015; Gilson 2017; Henry 2013; Lyndrup 1994; Mundle 2017; Shechter‐Maor 2015). Of these seven studies, only three studies contributed data for the meta‐analysis (Gilson 2017; Lyndrup 1994; Mundle 2017). The other four studies reported on maternal satisfaction with continuous data. Because of the importance of this outcome, we decided to report these results in narrative form.

Source of trial funding

Only 14 trials provided details for their funding sources: Filho 2002 received financial support from CAPES. Guinn 2000 reported that UpJohn Pharmaceuticals provided funds to purchase study drugs. Kruit 2016 received a grand from the Finnish medical society Duodecim and Helsinky university central hospital. Lokkegaard 2015 reported the randomisation procedure was funded by Snedkermester Sophus Jacobsen & Astrid Jacobsens fond and the Danish Toyota Foundation. Mackeen 2018 received a small internal grant to assist with the conduct and statistical analyses for the entire study. Mundle 2017 received funding from the Department for International Development, Medical Research Council, and Wellcome Trust Joint Global Health Trials Scheme. The study of Pennell 2009 was supported by a grant from the Women and Infants Research Foundation and Adeza Biomedical Corporation contributed support for the fetal fibronectin test kits. Roberts 1986 and Sullivan 1996 stated they were supported by the Vicksburg hospital medical foundation. Salim 2011 received funding from the Emek medical centre. Tan 2015 reported that the double balloons were provided by Cook medical. ten Eikelder 2016 received funding from Fonds Nuts Ohra. Wang 2014 received financial support of The People’s Liberation Army. Wu 2017 received a grant from the Nature Science Foundation of China.

Twelve studies reported they received no funding (Aduloju 2016; El Khouly 2017; Garba 2016; Hoppe 2016; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Laddad 2013; Lanka 2014; Meetei 2015; Shechter‐Maor 2015; Somirathne 2017). All other studies did not provide information on received funding.

Declarations of interest

Thirty‐four studies declared no conflict of interest (Aduloju 2016; Ahmed 2016; Al‐Ibraheemi 2018; Amorosa 2017; Barda 2018; Chavakula 2015; Cromi 2012; Edwards 2014c; El Khouly 2017; Filho 2002; Garba 2016; Goonewardene 2014; Henry 2013; Hoppe 2016; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Kandil 2012; Kruit 2016; Laddad 2013; Lanka 2014; Lewis 1983; Lokkegaard 2015; Mackeen 2018; Meetei 2015; Noor 2015; Pennell 2009; Salim 2011; Shechter‐Maor 2015; Somirathne 2017;Tan 2015; ten Eikelder 2016; Wang 2014; Wu 2017).

Two studies reported they had conflicts of interest. Atad 1996 stated that the first author has a patent licensing arrangement for Atad ripening device and thus has the potential gain from its sales. Mundle 2017 reported that one of the authors was a scientific adviser to Azanta, a Danish pharmaceutical company.

The remaining studies did not report whether any conflicts of interest were present.

Excluded studies

In total, 139 studies were excluded (see Characteristics of excluded studies), 75 studies (104 reports) in this update. In this update, most of the excluded trials (54 studies) made comparisons not within the scope of this review (Ahmad 2015; Arsenijevic 2012; Arshad 2016; Caughey 2007; Connolly 2016; Connolly 2017; Demirel 2015; Edwards 2017; El‐Khayat 2016; El Sharkwy 2017; Forgie 2016; Forooshani 2011; Fruhman 2017; Gadel 2015; Ghanaei 2009; Ghanaie 2013; Gibson 2013; Gu 2015; Haghighi 2015; Hallak 2008; He 2000; Hill 2013; Hussein 2012; Ifnan 2006; Jonsson 2011; Kehl 2012; Kehl 2015; Lam 2006; Leong 2017; Levine 2016; Lutgendorf 2012; Manish 2016; Mattingly 2015; McGee 2016; Mei‐Dan 2012a; Mei‐Dan 2014; Movahed 2016; Mullin 2014; Neethurani 2013; Rameez 2007; Rezk 2014; Saad 2016; Salmeen 2012; Sandberg 2017; Schoen 2017; Sharma 2015a; Sharma 2017; Siddiqui 2013; Torbenson 2015;Walfisch 2015; Wickramasinghe 2014; Wilkinson 2015; Yaddehige 2015; Zakaria 2017). Four studies were not randomised trials (Du 2015; Miller 2015; Naseem 2007; Nasir 2012) and one study did a cross‐over after 24 hours (Ugwu 2013). Thirteen trial registration were excluded because they exceeded the participated end date by more than two years and it was presumed the trial was terminated before enrolment (Anabosy 2014; Baacke 2006; Behrashi 2013; Cullimore 2009; Dias 2008 EUCTR 2012; Kamilya 2011; Mei‐Dan 2012; Park 2011 Pathiraja 2014; Reif 2012; Yazdani 2011; Zhang 2014). One study Husain 2017 was initially included in this update but subsequently excluded because the study has since been retracted. For more information, see Characteristics of excluded studies.

Risk of bias in included studies

The quality assessments are graphically summarised in Figure 2 and Figure 3.

Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

This review update includes nine comparisons with more than 10 studies, of which we constructed funnel plots (Figure 4; Figure 5; Figure 6; Figure 7; Figure 8; Figure 9; Figure 10; Figure 11; Figure 12). Visual inspection of one funnel plot (Figure 5) was somewhat asymmetrical suggesting some form of publication bias for this outcome (oxytocin augmentation) for the comparison of a balloon versus vaginal PGE2. Visual assessment of the other funnel plots did not show asymmetry, suggesting there is no publication bias for these comparisons.

Figure 4

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.3 Caesarean section.

Figure 5

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.6 Oxytocin augmentation.

Figure 6

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.7 Uterine hyperstimulation without fetal heart rate changes.

Figure 7

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.10 Instrumental vaginal delivery.

Figure 8

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.12 Apgar score < 7 at 5 minutes.

Figure 9

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.13 Neonatal intensive care unit admission.

Figure 10

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.21 Fetal distress.

Figure 11

Funnel plot of comparison: 4 Balloon (Foley or ATAD) versus intracervical Prostaglandin E2: all women, outcome: 4.3 Caesarean section.

Figure 12

Funnel plot of comparison: 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, outcome: 7.3 Caesarean section.

Allocation

Sequence generation

We judged 61 trials to be at low risk of selection bias, reporting some form of adequate random sequencing such as a computer‐generated sequence or a list of random numbers (Aduloju 2016; Ahmed 2016; Al‐Ibraheemi 2018; Al‐Taani 2004; Amorosa 2017; Atad 1996; Bagratee 1990; Blumenthal 1990; Browne 2011; Carbone 2013; Chavakula 2015; Chua 1997; Cromi 2011; Cromi 2012; Culver 2004; Deo 2012; Edwards 2014c; El Khouly 2017; Filho 2002; Garba 2016; Gelisen 2005; Goonewardene 2014; Guinn 2000; Henry 2013; Hibbard 1998; Johnson 1985; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Khamaiseh 2012; Krammer 1995a; Lanka 2014; Lokkegaard 2015; Mackeen 2018; Matonhodze 2003; Mazhar 2003; Meetei 2015; Mullin 2002; Mundle 2017; Niromanesh 2003; Oliveira 2010; Ophir 1992; Orhue 1995; Perry 1998; Prager 2008; Rouben 1993; Salim 2011; Sanchez‐Ramos 1992; Sciscione 1999; Sharami 2005; Shechter‐Maor 2015; Solt 2009; Somirathne 2017; St Onge 1995; Suffecool 2014; Tabowei 2003; Tan 2015; ten Eikelder 2016; Turnquest 1997; Wang 2012; Yuen 1996).

Three trials were classified as high risk because they were quasi‐randomised trials. Jagani 1982 randomised by last digit of the chart number, Kandil 2012 randomised by odd or even admission date and Roztocil 1998 randomised by week of admission.

We judged the remaining 40 trials to be at unclear risk of selection bias, as they did not report on how a random sequence was generated (Allouche 1993; Barda 2018; Benzineb 1996; Casey 1995; Dalui 2005; Deshmukh 2011; Dionne 2011; Gilson 2017; Glagoleva 1999; Gunawardena 2012; Haugland 2012; Hay 1995; Hemlin 1998; Hoppe 2016; Hudon 1999; Jeeva 1982; Joshi 2016; Kruit 2016; Kuppulakshmi 2016; Laddad 2013; Lemyre 2006; Lewis 1983; Lyndrup 1989; Lyndrup 1994; Moini 2003; Noor 2015; Ntsaluba 1997; Pennell 2009; Pineda Rivas 2016; Ridgway 1991; Roberts 1986; Roudsari 2011; Rudra 2012; Saleem 2006; Sarreau 2016; Sheikher 2009; Sullivan 1996;Tita 2006; Wang 2014; Wu 2017).

Allocation concealment

Fifty‐four studies reported a method of allocation concealment likely to have a low risk of bias, either by central randomisation or sequentially numbered, sealed, opaque envelopes (Aduloju 2016; Ahmed 2016; Al‐Ibraheemi 2018; Amorosa 2017; Blumenthal 1990; Browne 2011; Carbone 2013; Chavakula 2015; Cromi 2012; Culver 2004; Deo 2012; Edwards 2014c; El Khouly 2017; Filho 2002; Gelisen 2005; Goonewardene 2014; Guinn 2000; Hemlin 1998; Henry 2013; Hibbard 1998; Hoppe 2016; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Kruit 2016; Lanka 2014; Lokkegaard 2015; Lyndrup 1989; Lyndrup 1994; Matonhodze 2003; Mullin 2002; Mundle 2017; Niromanesh 2003; Ntsaluba 1997; Oliveira 2010; Orhue 1995; Pennell 2009; Perry 1998; Prager 2008; Roberts 1986; Rouben 1993; Salim 2011; Sciscione 1999; Sharami 2005; Somirathne 2017; St Onge 1995; Suffecool 2014; Sullivan 1996; Tabowei 2003; Tan 2015; ten Eikelder 2016; Turnquest 1997; Wang 2014; Yuen 1996).

Five studies were judged to be high risk. In the quasi‐randomised trials of Jagani 1982, Kandil 2012 and Roztocil 1998 no measures were taken to conceal the allocation; Mackeen 2018 stated that the allocation was not concealed and Ophir 1992 allocated women by odd or even randomisation number.

The remaining 45 studies did not report a method for concealing allocation and were judged as being at unclear risk of bias (Allouche 1993; Al‐Taani 2004; Atad 1996; Bagratee 1990; Barda 2018; Benzineb 1996; Casey 1995; Chua 1997; Cromi 2011; Dalui 2005; Deshmukh 2011; Dionne 2011; Garba 2016; Gilson 2017; Glagoleva 1999; Gunawardena 2012; Haugland 2012; Hay 1995; Hudon 1999; Jeeva 1982; Johnson 1985; Joshi 2016; Khamaiseh 2012; Krammer 1995a; Kuppulakshmi 2016; Laddad 2013; Lemyre 2006; Lewis 1983; Mazhar 2003; Meetei 2015; Moini 2003; Noor 2015; Pineda Rivas 2016; Ridgway 1991; Roudsari 2011; Rudra 2012; Saleem 2006; Sanchez‐Ramos 1992; Sarreau 2016; Shechter‐Maor 2015; Sheikher 2009; Solt 2009; Tita 2006; Wang 2012; Wu 2017).

Blinding

Performance bias

Given the nature of the intervention (mechanical methods for induction of labour) and comparison (pharmacological methods for induction of labour), it was not possible for women or clinicians to be blinded to the treatment group in any of the trials. For the more objective outcomes such as perinatal death, the lack of blinding is unlikely to be a major source of bias. Therefore, risk of performance bias was judged as unclear in all studies, but was a reason to downgrade the quality of evidence from high to moderate.

Detection bias

It would have been possible for outcome assessment to have been undertaken by someone blinded to allocation groups. However, only four trials reported blinded outcome assessment (rated as low risk of bias). Gelisen 2005 blinded only for the outcome of hyperstimulation. In the studies of Pennell 2009 and Gelisen 2005, data were collected by research midwives who were blinded to the intervention. Rudra 2012 and Haugland 2012 both stated they performed a double blind‐trial but provided too little information to assess how this was done. The remaining 101 trials did not detail whether outcome assessment was blinded, and thus we judged risk of detection bias to be unclear. Measurement of outcomes such as perinatal death are unlikely to be biased by lack of blinding.

Incomplete outcome data

We considered 38 studies to be at low risk of attrition bias with data analyses according to intention‐ to‐treat and minimal/no loss to follow‐up or exclusion of women (Aduloju 2016; Al‐Ibraheemi 2018; Al‐Taani 2004; Amorosa 2017; Atad 1996; Carbone 2013; Chavakula 2015; Chua 1997; Cromi 2011; Culver 2004; Dalui 2005; Deshmukh 2011; Edwards 2014c; El Khouly 2017; Filho 2002; Guinn 2000; Henry 2013; Jeeva 1982; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Lanka 2014; Lokkegaard 2015; Mackeen 2018; Mullin 2002; Mundle 2017; Noor 2015; Ntsaluba 1997; Oliveira 2010; Pennell 2009; Perry 1998; Prager 2008; Roberts 1986; Roztocil 1998; Suffecool 2014; Sullivan 1996; ten Eikelder 2016; Wu 2017).

Forty‐three studies were judged to be at unclear risk of attrition bias, mainly because it was not clear if intention‐to‐treat analyses was used (Allouche 1993; Benzineb 1996; Garba 2016; Gelisen 2005; Hemlin 1998; Hibbard 1998; Hoppe 2016; Jagani 1982; Johnson 1985; Joshi 2016; Khamaiseh 2012; Laddad 2013; Lewis 1983; Matonhodze 2003; Meetei 2015; Niromanesh 2003; Roudsari 2011; Salim 2011; Sanchez‐Ramos 1992; Sharami 2005; Shechter‐Maor 2015; Somirathne 2017; St Onge 1995), or there was too little information to judge attrition bias (Barda 2018; Casey 1995; Dionne 2011; Gilson 2017; Glagoleva 1999; Gunawardena 2012; Haugland 2012; Hay 1995; Hudon 1999; Kuppulakshmi 2016; Lemyre 2006; Mazhar 2003; Moini 2003; Pineda Rivas 2016; Ridgway 1991; Rudra 2012; Saleem 2006; Sarreau 2016; Solt 2009; Tabowei 2003).

Twenty‐three studies were classified as high risk for attrition bias. In the studies of Ahmed 2016, Cromi 2012 and Wang 2014, women were excluded because of failed placement of the balloon. Kandil 2012 also excluded nine patients because of failed placement of the Foley catheter, but replaced them with women who did receive a Foley catheter. Deo 2012 analysed data as treated and also four cases went missing without a given explanation. Kruit 2016, Lyndrup 1989, Sciscione 1999, Tan 2015, Turnquest 1997, Wang 2012 and Yuen 1996 excluded cases because of protocol violation and Krammer 1995a reported they analysed intention‐to‐treat, but eventually excluded women because of protocol violation or if they delivered within six hours after induction had started. Goonewardene 2014 also excluded women if they went into spontaneous labour after the intervention. Lyndrup 1994 excluded women if they delivered after 48 hours of induction had started. Orhue 1995 excluded women if they had an unfavourable cervix after 12 hours of induction. Rouben 1993 excluded women after failed induction. The studies of Bagratee 1990, Blumenthal 1990, Browne 2011, Ophir 1992, Sheikher 2009, Tita 2006 were judged to be of high risk for attrition bias because cases were missing without a given explanation.

Selective reporting

Seventy‐one studies were judged to be at low risk of reporting bias as all pre‐specified outcomes were reported (Aduloju 2016; Al‐Ibraheemi 2018; Al‐Taani 2004; Amorosa 2017; Atad 1996; Bagratee 1990; Barda 2018; Blumenthal 1990; Carbone 2013; Chavakula 2015; Chua 1997; Cromi 2011; Cromi 2012; Culver 2004; Dalui 2005; Deo 2012; Deshmukh 2011; Edwards 2014c; El Khouly 2017; Filho 2002; Garba 2016; Gelisen 2005; Goonewardene 2014; Guinn 2000; Hemlin 1998; Henry 2013; Hibbard 1998; Hoppe 2016; Jagani 1982; Johnson 1985; Joshi 2016; Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; Kandil 2012; Khamaiseh 2012; Krammer 1995a; Kruit 2016; Kuppulakshmi 2016; Lanka 2014; Lokkegaard 2015; Lyndrup 1994; Mackeen 2018; Matonhodze 2003; Mazhar 2003; Meetei 2015; Mullin 2002; Mundle 2017; Noor 2015; Ntsaluba 1997;Oliveira 2010; Ophir 1992; Orhue 1995; Pennell 2009; Perry 1998; Prager 2008; Rouben 1993; Roztocil 1998; Salim 2011; Sciscione 1999; Sharami 2005; Solt 2009; Somirathne 2017; St Onge 1995; Suffecool 2014; Sullivan 1996; Tabowei 2003; ten Eikelder 2016; Turnquest 1997; Wang 2012;Wu 2017; Yuen 1996). It is important to note that not all studies had a trial protocol available and therefore it was not possible to check if there were other pre‐specified outcomes not reported in the method section of the article.

Twenty‐eight studies were judged to be of unclear risk of reporting bias. In 10 studies no outcomes were pre‐specified in the methods section (Allouche 1993; Benzineb 1996; Jeeva 1982; Laddad 2013; Lewis 1983; Lyndrup 1989; Roberts 1986; Sanchez‐Ramos 1992; Tan 2015; Wang 2014 and in 18 studies there was too little information to judge reporting bias (Casey 1995; Dionne 2011; Gilson 2017; Glagoleva 1999; Guinn 2000; Gunawardena 2012; Haugland 2012; Hay 1995; Hudon 1999; Lemyre 2006; Moini 2003; Niromanesh 2003; Pineda Rivas 2016; Ridgway 1991; Roudsari 2011; Rudra 2012; Saleem 2006; Sarreau 2016).

The studies of Ahmed 2016, Browne 2011, Shechter‐Maor 2015, Sheikher 2009 and Tita 2006 were judged as high risk as not all pre‐specified outcomes were reported in the results section.

Other potential sources of bias

For 24 studies it was not clear if there was another source of bias and these were therefore judged as unclear. For one study (Barda 2018), only a manuscript with no tables was available. Two trials (Browne 2011; Tita 2006) were not published, but the results of the primary outcome and adverse events were reported in the trial registration. Guinn 2000 stopped recruiting women for one arm of the study without an explanation. Mullin 2002 calculated a sample size of 140 women but included 200 women without explanation. Prager 2008 included patients who did not meet inclusion criteria. Eighteen studies were only published as abstracts, or there was too little information provided and so it was not possible to judge the risk of bias (Casey 1995; Dionne 2011; Garba 2016; Gilson 2017; Glagoleva 1999; Haugland 2012; Hay 1995; Hudon 1999; Lemyre 2006; Oliveira 2010; Pineda Rivas 2016; Ridgway 1991; Rudra 2012; Sarreau 2016; Shechter‐Maor 2015; Solt 2009; Tabowei 2003; Wang 2012).

The studies of Culver 2004, Hibbard 1998, and Kruit 2016 were judged as high risk for other potential sources of bias as they were terminated early before the required sample size was recruited.

Effects of interventions

See: Summary of findings 1 Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus; Summary of findings 2 Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus; Summary of findings 3 Balloon (Foley or ATAD) compared to low‐dose oral misoprostol for third trimester induction of labour in women with a viable fetus

Balloon (single or double) versus vaginal prostaglandin E2 (28 trials involving 6619 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

There may be little or no difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal PGE2 (average risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; low‐quality evidence; Analysis 1.1), although there was substantial heterogeneity for this outcome (Tau² = 0.06; Chi² = 29.06, df = 6 (P =< 0.0001); I² = 79%).

A sensitivity analysis, after eliminating the two trials assessed as having a potentially higher risk of concealment or attrition bias (Cromi 2012; Wang 2014), did not change the effect observed, despite the result becoming less precise (average RR 1.10, 95% CI 0.86 to 1.41; 1351 women; 5 studies; I² = 82%).

The same result was seen on a subgroup comparison for primiparous women (RR 1.01, 95% CI 0.83 to 1.23; 330 women; 1 study; Analysis 2.1). While for multiparous women, a balloon catheter may increase the risk of a vaginal delivery not being achieved within 24 hours (RR 4.38, 95% CI 1.74 to 10.98; 147 women; 1 study; Analysis 3.1).

Uterine hyperstimulation with fetal heart rate (FHR) changes

A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes when compared to vaginal PGE2 (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate‐quality evidence; Analysis 1.2), the absolute effect being 21 less per 1000 deliveries.

The same result was seen on a subgroup comparison for primiparous women (RR 0.05, 95% CI 0.00 to 0.85; 330 women; 1 study; Analysis 2.2). For multiparous women, no outcomes were reported.

Caesarean section

There probably is little or no difference in caesarean sections between both induction methods (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate‐quality evidence; Analysis 1.3). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 4).

It is uncertain whether there is a difference in caesarean sections between both induction methods on subgroups for both primiparous women (average RR 0.89, 95% CI 0.59 to 1.33; 828 women; 5 studies; Analysis 2.3) and multiparous women (RR 1.31, 95% CI 0.65 to 2.63; 180 women; 2 studies; Analysis 3.2) as the results of these outcomes were imprecise. Furthermore, for the primiparous group, there was also substantial heterogeneity (Tau² = 0.11; Chi² = 10.01, df = 4 (P = 0.04); I² = 60%).

Serious neonatal morbidity or perinatal death

A balloon catheter probably reduces the risk of serious neonatal morbidity or perinatal death when compared to vaginal PGE2 (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate‐quality evidence; Analysis 1.4). However, numbers are low (12/1483 versus 25/1274, respectively) and almost all of these numbers were cases of birth asphyxia. Only two perinatal deaths were reported, both in the PGE2 group (Edwards 2014c). No heterogeneity was seen for this outcome.

For primiparous women, it is uncertain whether there is a difference in effect as the result for this outcome was imprecise (RR 0.17, 95% CI 0.01 to 4.24; 330 women; 1 study; Analysis 2.4). For multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women; very low‐quality evidence; Analysis 1.5). Of all the 28 studies included for this comparison, only four studies reported on this composite outcome. No events were reported in the balloon group. One author (Jozwiak 2012) reported two events in the PGE2 group, both events being uterine rupture.

Only one study (60 women) reported on this outcome in primiparous women, in which no events were seen (Analysis 2.5). For multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

Induction of labour with a balloon catheter may increase the risk of oxytocin augmentation when compared to vaginal PGE2 (average RR 1.54, 95% CI 1.35 to 1.76; 4828 women; 16 studies; Analysis 1.6), although there was substantial heterogeneity for this outcome (Tau² = 0.05; Chi² = 141.47, df = 15 (P = < 0.0001); I² = 89%). Visual inspection of the funnel plot was somewhat asymmetrical, suggesting some form of publication bias (Figure 5).

A sensitivity analysis, after eliminating the five trials assessed as having a potentially higher risk of allocation or attrition bias (Cromi 2012; Deo 2012; Tan 2015; Wang 2012; Wang 2014), did not alter the result, nor did it lower heterogeneity (average RR 1.37, 95% CI 1.21 to 1.54; 4005 women; 11 studies; I² = 87%).

Uterine hyperstimulation without FHR changes

A balloon catheter may reduce the risk of uterine hyperstimulation without FHR changes when compared to vaginal PGE2 (average RR 0.27, 95% CI 0.11 to 0.66; 2444 women; 15 studies; Analysis 1.7), although there was moderate heterogeneity for this outcome (Tau² = 1.13; Chi² = 22.28, df = 12 (P = 0.03); I² = 46%). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 6).

A sensitivity analysis, after eliminating the seven trials assessed as having a potentially higher risk of allocation or attrition bias (Deo 2012; Orhue 1995; Shechter‐Maor 2015; Tan 2015; Wang 2012; Wang 2014; Zahoor 2014), made this result less precise and therefore raises uncertainty as to whether there is a difference in uterine hyperstimulation without FHR changes (average RR 0.26, 95% CI 0.06 to 1.05; 1694 women; 8 studies; I² = 62%).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (RR 0.20, 95% CI 0.01 to 4.12; 1045 women; 2 studies; Analysis 1.8). Only two cases of uterine rupture were reported, both in the PGE2 group in the study of Jozwiak 2012. Uterine rupture was defined by the authors as a separation of the uterine wall, and in one case this was caused by inserting an intrauterine pressure catheter.

Epidural analgesia

A balloon catheter may slightly increase the use of epidural analgesia during labour when compared to vaginal PGE2 (average RR 1.14, 95% CI 1.00 to 1.29; 2828 women; 8 studies; Analysis 1.9). However, there was substantial heterogeneity for this outcome (Tau² = 0.02; Chi² = 32.09, df = 7 (P = < 0.0001); I² = 78%).

A sensitivity analysis, after eliminating the two trials assessed as having a potentially higher risk of allocation or attrition bias (Cromi 2012; Tan 2015), did not alter the result, nor did it lower heterogeneity (average RR 1.11, 95% CI 0.97 to 1.28; 2537 women; 6 studies; I² = 80%).

Instrumental vaginal delivery

There probably is little or no difference in instrumental vaginal deliveries between both induction methods (RR 0.93, 95% CI 0.79 to 1.09; 4514 women; 16 studies; Analysis 1.10). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 7).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.89, 95% CI 0.67 to 1.19; 964 women; 4 studies; Analysis 1.11).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar score less than seven at five minutes between both induction methods (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies; low‐quality evidence; Analysis 1.12). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 8).

Neonatal intensive care unit (NICU) admission

A balloon catheter may reduce the risk of a NICU admission when compared to vaginal PGE2 (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low‐quality evidence; Analysis 1.13), the absolute effect being 15 fewer NICU admission per 1000 deliveries. Although it should be noted that there is a wide range of treatment effects that are compatible with the data, from a very small increase in risk to very large decrease. Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 9).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both induction methods (RR 0.21, 95% CI 0.01 to 4.27; 1036 women; 5 studies; Analysis 1.14). Only two cases of perinatal death were reported by Edwards 2014c, both being cases of neonatal death and born to women randomised to vaginal PGE2. The authors describe that in both cases the neonates died as a result of complications related to a congenital diaphragmatic hernia and were unrelated to the induction method.

Disability in childhood

Not reported.

Maternal side effects (all)

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 0.82, 95% CI 0.63 to 1.06; 2215 women; 8 studies; Analysis 1.15).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

A balloon catheter may reduce the amount of women not being satisfied with the induction method when compared to prostaglandin E2 (RR 0.61, 95% CI 0.39 to 0.97; 93 women; 1 study; Analysis 1.16), the absolute effect being 224 fewer women not satisfied per 1000 deliveries. This outcome was reported by Henry 2013 by asking the women if they would choose the randomised induction method again. Patient satisfaction was also reported by Shechter‐Maor 2015, but could not be included in the meta‐analysis. In this study women were asked to score their satisfaction with the induction process on a five‐point Likert scale. No difference in satisfaction was seen between both induction methods (3.41 (± 1.3) versus 3.33 (± 1.2), respectively; P = 0.860).

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

It is uncertain whether there is a difference in maternal fever during labour between both methods (RR 0.87, 95% CI 0.65 to 1.17; 2362 women; 7 studies; Analysis 1.17).

Antibiotics during labour

It is uncertain whether there is a difference in antibiotics during labour between both methods (RR 1.43, 95% CI 0.89 to 2.29; 330 women; 1 study; Analysis 1.18).

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 0.69, 95% CI 0.32 to 1.49; 376 women; 1 study; Analysis 1.19).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 0.49, 95% CI 0.19 to 1.27; 706 women; 2 studies; Analysis 1.20).

Fetal distress

A balloon catheter probably reduces the risk of fetal distress for which a caesarean section is indicated when compared to vaginal PGE2 (RR 0.71, 95% CI 0.60 to 0.83; 4753 women; 20 studies; Analysis 1.21). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 10).

Umbilical artery pH < 7.10

A balloon catheter probably reduces the risk of an umbilical artery pH less than 7.10 directly postpartum when compared to vaginal PGE2 (RR 0.65, 95% CI 0.44 to 0.94; 2675 women, 8 studies; Analysis 1.22). However, numbers occurred infrequently in both groups (35 per 1000 versus 56 per 1000, respectively).

Balloon (single or double) versus cervical prostaglandin E2 (10 trials involving 1428 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

It is uncertain whether there is a difference in vaginal deliveries achieved within 24 hours between induction of labour with a balloon catheter and cervical PGE2 (average RR 1.01, 95% CI 0.35 to 2.91; 200 women; 2 studies; Analysis 4.1). There also was substantial heterogeneity for this outcome (Tau² = 0.53; Chi² = 10.35, df = 1 (P = 0.001); I² = 90%). Even though data were pooled, both studies may be incompatible as no overlap of CIs is present. No sensitivity analysis was conducted as no potential high‐risk studies were included for this outcome.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (RR 0.37, 95% CI 0.02 to 8.90; 447 women; 4 studies; Analysis 4.2).

Only one small study (53 women) reported this outcome for the subgroups of primiparous and multiparous women. No events were reported in primiparous women (Analysis 5.1). For multiparous women, it is uncertain whether there is a difference for this outcome between both induction methods (RR 0.30, 95% CI 0.01 to 7.02; 53 women; 1 study; Analysis 6.1).

Caesarean section

There probably is little or no difference in caesarean sections between both induction methods (RR 0.97, 95% CI 0.81 to 1.15; 1309 women; 9 studies; Analysis 4.3). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 11).

It is uncertain whether there is a difference in caesarean sections between both induction methods on subgroup comparisons for both primiparous women (RR 1.30, 95% CI 0.86 to 1.95; 245 women; 3 studies; Analysis 5.2) and multiparous women (average RR 0.66, 95% CI 0.16 to 2.78; 136 women; 3 studies; Analysis 6.2) as the results for both comparisons were imprecise. For the multiparous group, there also was substantial heterogeneity (Tau² = 0.90; Chi² = 4.78, df = 2 (P = 0.09); I² = 58%).

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 0.78, 95% CI 0.29 to 2.05; 500 women; 2 studies; Analysis 4.4). Of the 10 studies included for this comparison, two studies (Benzineb 1996; Laddad 2013) reported on this composite outcome. All reported events in these studies were cases of perinatal death.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

Not reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

It is uncertain whether there is a difference in an unfavourable cervix after 24 hours between both induction methods (RR 0.96, 95% CI 0.70 to 1.34; 219 women; 2 studies; Analysis 4.5).

Oxytocin augmentation

There may be little or no difference in oxytocin augmentation between both induction methods (RR 1.08, 95% CI 0.93 to 1.26; 400 women; 1 study; Analysis 4.6).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (average RR 0.99, 95% CI 0.09 to 10.38; 654 women; 5 studies; Analysis 4.7). Also, there was substantial heterogeneity for this outcome (Tau² = 2.92; Chi² = 6.33, df = 2 (P = 0.04); I² = 68%).

A sensitivity analysis, after eliminating the two trials assessed as having a potentially higher risk of allocation or attrition bias (Sciscione 1999; Yuen 1996) did not alter the result, nor did it lower heterogeneity (average RR 0.56, 95% CI 0.01 to 39.31; 430 women; 3 studies; I² = 76%).

Uterine rupture

Not reported.

Epidural analgesia

There may be little or no difference in epidural analgesia during labour between both induction methods (RR 0.91, 95% CI 0.81 to 1.02; 149 women; 1 study; Analysis 4.8).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 1.18, 95% CI 0.68 to 2.05; 337 women; 3 studies; Analysis 4.9).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 1.17, 95% CI 0.42 to 3.26; 118 women; 1 study; Analysis 4.10).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes (RR 0.79, 95% CI 0.41 to 1.53; 475 women; 2 studies; Analysis 4.11).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both methods (RR 0.88, 95% CI 0.60 to 1.31; 400 women; 1 study; Analysis 4.12).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is difference in perinatal death between both induction methods (RR 0.78, 95% CI 0.29 to 2.05; 500 women; 2 studies. Analysis 4.13). Noteworthy, there was a relatively high number of neonatal deaths reported in the study of Laddad 2013 for the balloon group (6/200), as well as in the cervical PGE2 group (8/200), for which no explanation was given by the authors.

Disability in childhood

Not reported.

Maternal side effects

It is uncertain whether there is a difference in maternal side effects (RR 0.15, 95% CI 0.02 to 1.24; 211 women; 2 studies; Analysis 4.14). The nature of the side effects was not specified in both included studies.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 0.20, 95% CI 0.01 to 4.06; 100 women; 1 study; Analysis 4.15).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 1.00, 95% CI 0.21 to 4.75; 118 women; 1 study; Analysis 4.16).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 1.00, 95% CI 0.06 to 15.61; 118 women; 1 study; Analysis 4.17).

Fetal distress

A balloon catheter probably reduces the risk of fetal distress for which a caesarean section is indicated when compared to cervical PGE2 (RR 0.61, 95% CI 0.42 to 0.89; 1023 women; 6 studies; Analysis 4.18).

Umbilical artery pH < 7.10

Not reported.

Balloon (single or double) versus low‐dose vaginal misoprostol (13 trials involving 1818 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

It is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low‐quality evidence; Analysis 7.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes when compared to vaginal misoprostol (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; moderate‐quality evidence; 8 studies; Analysis 7.2), the absolute effect being 22 fewer cases per 1000 deliveries.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

A balloon catheter may increase the risk of a caesarean section when compared to vaginal misoprostol (average RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; low‐quality evidence; Analysis 7.3), the absolute effect being 53 more caesarean sections per 1000 deliveries. However, there was moderate heterogeneity for this outcome (Tau² = 0.06; Chi² = 19.86, df = 11 (P = 0.05); I² = 45%).

A sensitivity analysis, after eliminating the three trials assessed as having a potentially higher risk of allocation or attrition bias (Deo 2012; Kandil 2012; Sheikher 2009), did not alter the result, nor did it lower heterogeneity (average RR 1.34, 95% CI 1.05 to 1.71; 1492 women; 10 studies; I² = 48%). Visual inspection of the funnel plot associated with this outcome does not suggest any evidence of publication bias (Figure 12).

For the subgroup of primiparous women, it is uncertain whether there is a difference in caesarean sections between both induction methods (RR 0.82, 95% CI 0.59 to 1.13; 255 women; 1 study; Analysis 8.1). For multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies; very low‐quality evidence; Analysis 7.4). All of the cases included for this composite outcome were cases of perinatal asphyxia (2/187 versus 4/194, respectively).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (very low‐quality evidence; Analysis 7.5). Of the 13 studies included for this comparison, four studies (464 women) reported on this composite outcome. No events of maternal morbidity or death occurred in one of these studies.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 12 hours

It is uncertain whether there is a difference in an unfavourable cervix after 12 hours between both induction methods (average RR 2.66, 95% CI 0.60 to 11.89; 200 women; 2 studies; Analysis 7.6). Also, there was moderate heterogeneity for this outcome (Tau² = 0.63; Chi² = 1.56, df = 1 (P = 0.21); I² = 36%). No studies reported on a time period of 24 hours.

A sensitivity analysis, after eliminating one trial assessed as having a potentially higher risk of allocation or attrition bias (Sheikher 2009), did not change the result, but did narrow the CI (RR 1.82, 95% CI 0.94 to 3.51; 1 study).

Oxytocin augmentation

A balloon catheter probably increases the risk of oxytocin augmentation when compared to vaginal misoprostol (average RR 1.62, 95% CI 1.38 to 1.90; 911 women; 9 studies; Analysis 7.7), although there was substantial heterogeneity for this outcome (Tau² = 0.03; Chi² = 21.93, df = 8 (P = 0.005); I² = 64%).

In the sensitivity analysis, after eliminating two trial assessed as having a potentially higher risk of allocation or attrition bias (Kandil 2012 and Sheikher 2009), heterogeneity was lost without altering the effect observed (average RR 1.50, 95% CI 1.36 to 1.64; 751 women, 7 studies; I² = 0%).

Uterine hyperstimulation without FHR changes

A balloon catheter probably reduces the risk of uterine hyperstimulation without FHR changes when compared to vaginal misoprostol (RR 0.25, 95% CI 0.14 to 0.44; 1139 women; 9 studies; Analysis 7.8).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 7.9). Of the 13 studies included for this comparison, only three studies (364 women) reported on this outcome. No events of uterine rupture occurred in one of these studies.

Epidural analgesia

A balloon catheter probably slightly increases the use of epidural analgesia during labour when compared to vaginal misoprostol (RR 1.22, 95% CI 1.06 to 1.41; 517 women; 2 studies; Analysis 7.10).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.72, 95% CI 0.50 to 1.05; 721 women; 4 studies; Analysis 7.11).

Meconium‐stained liquor

A balloon catheter probably reduces the risk of meconium‐stained liquor when compared to vaginal misoprostol (RR 0.64, 95% CI 0.48 to 0.87; 1268 women; 7 studies; Analysis 7.12).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies; low‐quality evidence; Analysis 7.13).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both induction methods (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies; low‐quality evidence; Analysis 7.14).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is difference in perinatal death between both induction methods (Analysis 7.15). Of the 13 studies included for this comparison, only one study (121 women) pre‐specified this outcome. No cases of perinatal death were reported in this study.

Disability in childhood

Not reported.

Maternal side effects (all)

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

It is uncertain whether there is difference in maternal vomiting between both induction methods (Analysis 7.16). Of all the 13 studies included for this comparison, only one study (60 women) pre‐specified this outcome. No cases of maternal vomiting were reported in this study.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is difference in postpartum haemorrhage between both induction methods (RR 1.14, 95% CI 0.24 to 5.44; 120 women; 1 study; (Analysis 7.17).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

One study (Chavakula 2015) reported on patient satisfaction, but could not be included in the meta‐analysis. In this study, satisfaction was assessed by a visual analogue score ranging from zero to five (0 = very poor; 5 = very good), in which no difference between both induction methods was seen (100 women; 4.5 [4‐5] versus 4.45 [3‐5], respectively; P = 0.488).

Caregiver not satisfied

Not reported.

Not pre‐specified outcomes

Maternal fever during labour

It is uncertain whether there is a difference in maternal fever during labour between both methods (average RR 1.84, 95% CI 0.22 to 15.62; 617 women; 3 studies; Analysis 7.18). Also, there was substantial heterogeneity for this outcome (Tau² = 1.86; Chi² = 3.95, df = 1 (P = 0.05); I² = 75%). No sensitivity analysis was performed as no potential high‐risk studies were included for this outcome.

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 1.24, 95% CI 0.31 to 4.88; 200 women; 2 studies; Analysis 7.19).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 2.95, 95% CI 0.12 to 71.72; 240 women; 1 study; Analysis 7.20).

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated (RR 0.84, 95% CI 0.67 to 1.05; 1127 women; 7 studies; Analysis 7.21).

Umbilical artery pH < 7.10

It is uncertain whether there is a difference in umbilical artery pH less than 7.10 directly postpartum between both induction methods (RR 1.14, 95% CI 0.35 to 3.74; 120 women; 1 study; Analysis 7.22).

Balloon (single or double) versus low‐dose oral misoprostol (seven trials involving 3178 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

A balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours when compared to oral misoprostol (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies. moderate‐quality evidence, Analysis 9.1), the absolute effect being 133 more per 1000 deliveries.

The same results were seen on parity subgroup comparisons for primiparous women (RR 1.19, 95% CI 1.04 to 1.37; 573 women; 2 studies; Analysis 10.1) and multiparous women (RR 1.55, 95% CI 1.17 to 2.06; 209 women; 2 studies; Analysis 11.1).

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies; low‐quality evidence; Analysis 9.2).

The same results were seen on parity subgroup comparisons for primiparous women (RR 0.81, 95% CI 0.45 to 1.46; 1206 women; 1 study; Analysis 10.2 and multiparous women (RR 1.45, 95% CI 0.24 to 8.61; 639 women; 1 study; Analysis 11.2).

Caesarean section

A balloon catheter probably slightly increases the risk of a caesarean section when compared to oral misoprostol (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; moderate‐quality evidence; Analysis 9.3), the absolute effect being 37 more caesarean sections per 1000 deliveries.

The same result was seen on the subgroup of primiparous women (RR 1.21, 95% CI 1.06 to 1.38; 1778 women; 3 studies; Analysis 10.3). For multiparous women, it is uncertain whether there is a difference in caesarean sections between both methods (RR 1.22, 95% CI 0.79 to 1.87; 848 women; 3 studies; Analysis 11.3).

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies; low‐quality evidence; Analysis 9.4).

The same results were seen on parity subgroup comparisons for primiparous women (RR 4.49, 95% CI 0.77 to 26.14; 1296 women; 2 studies; Analysis 10.4) and multiparous women (RR 0.98, 95% CI 0.14 to 6.86; 729 women; 2 studies; Analysis 11.4).

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies; very low‐quality evidence; Analysis 9.5).

The same results were seen on parity subgroup comparisons for primiparous women (RR 0.51, 95% CI 0.05 to 5.63; 1296 women; 2 studies; Analysis 10.5) and multiparous women (Analysis 11.5). In the latter group, no events of maternal morbidity or death were reported (2 studies; 729 women).

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

It is uncertain whether there is a difference in an unfavourable cervix after 24 hours between both induction methods (average RR 0.98, 95% CI 0.61 to 1.56; 994 women; 4 studies; Analysis 9.6). Also, there was moderate heterogeneity for this outcome (Tau² = 0.06; Chi² = 2.96, df = 2 (P = 0.23); I² = 33%).

A sensitivity analysis, after eliminating the two trials assessed as having a potentially higher risk of allocation or attrition bias (Goonewardene 2014; Sheikher 2009), did not change the result, although heterogeneity was lost (RR 1.31, 95% CI 0.81 to 2.15; 782 women; 2 studies; I² = 0%).

Oxytocin augmentation

A balloon catheter may increase the risk of oxytocin augmentation when compared to oral misoprostol (average RR 1.28, 95% CI 1.09 to 1.49; 2847 women; 5 studies; Analysis 9.7) although there was substantial heterogeneity for this outcome (Tau² = 0.03; Chi² = 31.32, df = 4 (P < 0.000001); I² = 87%).

A sensitivity analysis, after eliminating the three trials assessed as having a potentially higher risk of allocation or attrition bias (Goonewardene 2014; Kruit 2016; Sheikher 2009), did not change this result, nor did it lower heterogeneity (average RR 1.35, 95% CI 1.02 to 1.79; 2447 women; 2 studies; I² = 95%).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (average RR 0.50, 95% CI 0.12 to 2.07; 2838 women; 5 studies; Analysis 9.8). Also, there was substantial heterogeneity for this outcome (Tau² = 1.26; Chi² = 8.12, df = 4 (P = 0.09); I² = 51%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Sheikher 2009), did not change the effect observed, nor did it lower heterogeneity (average RR 0.49, 95% CI 0.09 to 2.64; 2778 women; 4 studies; I² = 60%).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 9.9). Of the seven studies included for this comparison, three studies (2627 women) pre‐specified this outcome. No events of uterine rupture occurred in any of these studies.

Epidural analgesia

A balloon catheter may slightly increase the risk for epidural analgesia when compared to oral misoprostol (average RR 1.08, 95% CI 0.96 to 1.22; 2635 women; 3 studies; Analysis 9.10). However, the result is still too imprecise to make a valid judgement on this outcome. Also, there was substantial heterogeneity for this outcome (Chi² = 4.73, df = 2 (P = 0.09); I² = 58%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Kruit 2016), did not change this result, but did lower heterogeneity for this outcome (RR 1.13, 95% CI 1.03 to 1.24; 2447; 2 studies; I² = 5%).

Instrumental vaginal delivery

A balloon catheter probably reduces the risk of an instrumental vaginal delivery when compared to oral misoprostol (RR 0.71, 95% CI 0.55 to 0.92; 2627 women; 3 studies; Analysis 9.11).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (average RR 0.77, 95% CI 0.44 to 1.35; 2627 women; 3 studies; Analysis 9.12). Also, there was moderate heterogeneity for this outcome (Tau² = 0.11; Chi² = 3.09, df = 2 (P = 0.21); I² = 35%). No sensitivity analysis was conducted as no potential high‐risk studies were included for this outcome.

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies; low‐quality evidence; Analysis 9.13).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both induction methods (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies; low‐quality evidence; Analysis 9.14).

Neonatal encephalopathy

It is uncertain whether there is a difference in neonatal encephalopathy between both induction methods (RR 0.81, 95% CI 0.32 to 2.03; 600 women; 1 study; Analysis 9.15).

Perinatal death

It is uncertain whether there is difference in perinatal death between both induction methods (RR 1.28, 95% CI 0.49 to 3.30; 2627 women; 3 studies; Analysis 9.16) as the result was imprecise and events occurred infrequently (9/1310 versus 7/1317, respectively). In the balloon group, two cases of perinatal death were related to asphyxia, compared to one case in the misoprostol group.

Disability in childhood

Not reported.

Maternal side effects (all)

It is uncertain whether there is a difference in maternal side effects between both induction methods (RR 0.61, 95% CI 0.33 to 1.13; 662 women; 2 studies; Analysis 9.17).

Maternal nausea

Not reported.

Maternal vomiting

It is uncertain whether there is a difference in maternal vomiting between both induction methods (RR 0.73, 95% CI 0.37 to 1.46; 662 women; 2 studies; Analysis 9.18).

Maternal diarrhoea

It is uncertain whether there is a difference in maternal diarrhoea between both induction methods (RR 0.29, 95% CI 0.06 to 1.37; 602 women; 1 study; Analysis 9.19).

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is difference in postpartum haemorrhage between both induction methods (RR 1.03, 95% CI 0.79 to 1.34; 2966 women; 5 studies; Analysis 9.20).

Serious maternal complications

Not reported.

Maternal death

It is uncertain whether there is a difference in maternal death between both induction methods (Analysis 9.21). Of the 13 studies included for this comparison, three studies (2627 women) pre‐specified this outcome. No events of maternal death occurred in one of these studies.

Woman not satisfied

A balloon catheter may increase the risk of women not being satisfied when compared to oral misoprostol (RR 1.70, 95% CI 1.15 to 2.50; 602 women; 1 study; Analysis 9.22), the absolute effect being 80 more women not satisfied per 1000 deliveries. In the one study included for this outcome, women were asked if they would choose the same induction method again in a future induction of labour.

Caregiver not satisfied

Not reported.

Not pre‐specified outcomes

Maternal fever during labour

There probably is little or no difference in maternal fever during labour between both induction methods (RR 0.98, 95% CI 0.78 to 1.24; 2033 women; 2 studies; Analysis 9.23).

Antibiotics during labour

It is uncertain whether there is a difference in antibiotics during labour between both induction methods (RR 1.22, 95% CI 0.75 to 2.00; 2033 women; 2 studies; Analysis 9.24).

Chorioamnionitis

Not reported.

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 0.56, 95% CI 0.05 to 6.03; 188 women; 1 study; Analysis 9.25).

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 0.82, 95% CI 0.61 to 1.09; 2966 women; 5 studies; Analysis 9.26).

Umbilical artery pH < 7.10

It is uncertain whether there is a difference in umbilical artery pH less than 7.10 directly postpartum between both induction methods (RR 0.77, 95% CI 0.53 to 1.12; 1535 women; 2 studies; Analysis 9.27).

Balloon (single or double) versus oxytocin (eight trials involving 781 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

Not reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between induction of labour with a balloon and oxytocin (RR 0.20, 95% CI 0.01 to 4.11; 200 women; 1 study; Analysis 12.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

A balloon catheter probably reduces the risk of a caesarean section when compared to oxytocin (RR 0.68, 95% CI 0.56 to 0.83; 781 women; 8 studies; Analysis 12.2), the absolute effect being 126 fewer caesarean sections per 1000 deliveries.

For women with a previous caesarean section, a balloon catheter may slightly reduce the risk of a caesarean section when compared to oxytocin (RR 0.80, 95% CI 0.64 to 1.00; 364 women; 3 studies; Analysis 13.1). However, the result is still too imprecise to make a valid judgement on this outcome.

For primiparous women, it is uncertain whether there is a difference in effect as the result of this outcome was imprecise (RR 0.43, 95% CI 0.12 to 1.50; 60 women; 1 study; Analysis 14.1). For multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (Analysis 12.3). Of the eight studies included for this comparison, one study (100 women) reported on this composite outcome. No events of neonatal morbidity or perinatal death occurred in this study.

The same result was seen on a subgroup of women with a previous caesarean section. One study (100 women) reported on this outcome, in which no events of serious neonatal morbidity of perinatal death occurred (Analysis 13.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 12.4). Of the eight studies included for this comparison, two studies (160 women) reported on this composite outcome. No events of serious maternal morbidity or death occurred in these studies.

The same result was seen on a subgroup of women with a previous caesarean section. One study (100 women) reported on this outcome, in which no events of serious maternal morbidity of death occurred (Analysis 13.3).

On parity subgroup comparisons, one study (60 women) reported on this outcome in primiparous women, in which no events were seen (Analysis 14.2). For multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

It is uncertain whether there is a difference in an unfavourable cervix after 24 hours between both induction methods (RR 0.56, 95% CI 0.20 to 1.54; 100 women; 1 study; Analysis 12.5).

Oxytocin augmentation

Not a relevant outcome because all women in the comparison group received oxytocin.

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (RR 1.00, 95% CI 0.23 to 4.29; 192 women; 3 studies; Analysis 12.6).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 12.7). Of the eight studies included for this comparison, one study (100 women) pre‐specified this outcome. No events of uterine rupture occurred in this study.

Epidural analgesia

Not reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 1.19, 95% CI 0.55 to 2.57; 220 women; 3 studies; Analysis 12.8).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.53, 95% CI 0.23 to 1.21; 272 women; 2 studies; Analysis 12.9).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 0.71, 95% CI 0.14 to 3.53; 300 women; 2 studies; Analysis 12.10).

Neonatal intensive care unit admission

It is uncertain whether there is difference in NICU admissions between both induction methods (RR 0.80, 95% CI 0.32 to 1.98; 372 women; 3 studies; Analysis 12.11).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both induction methods (Analysis 12.12). Of the eight studies included for this comparison, one study (100 women) pre‐specified this outcome. No cases of perinatal death occurred in this study.

Disability in childhood

Not reported.

Maternal side effects (all)

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is difference in postpartum haemorrhage between both induction methods (RR 1.26, 95% CI 0.51 to 3.11; 396 women; 4 studies; Analysis 12.13).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

It is uncertain whether there is difference in maternal fever during labour between both induction methods (RR 0.20, 95% CI 0.01 to 4.00; 60 women; 1 study; Analysis 12.14).

Antibiotics during labour

Not reported.

Chorioamnionitis

Not reported.

Endometritis

Not reported.

Fetal distress

A balloon catheter probably reduces the risk of fetal distress for which a caesarean section is indicated when compared to oxytocin (RR 0.43, 95% CI 0.19 to 0.98; 332 women; 3 studies; Analysis 12.15).

Umbilical artery pH < 7.10

Not reported.

Balloon (single or double) versus amniotomy (one trial involving 20 women)

The only outcome of interest reported for this comparison was caesarean section. Other outcomes were not reported.

Caesarean section

It is uncertain whether there is difference in caesarean sections between induction of labour with a balloon and amniotomy (RR 0.25, 95% CI 0.03 to 1.86; 20 women; 1 study; Analysis 15.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Singe balloon (Foley) versus double balloon (ATAD/Cook) (five trials involving 826 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

There may be little or no difference in vaginal deliveries not achieved within 24 hours between induction of labour with a single balloon and a double balloon (average RR 0.97, 95% CI 0.75 to 1.25; 608 women; 3 studies; Analysis 16.1), although there was substantial heterogeneity for this outcome (Chi² = 5.64, df = 2 (P = 0.06); I² = 65%). No sensitivity analysis was performed as no high‐risk studies were included for this outcome.

It is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between both induction methods on subgroups for both primiparous women (RR 1.14, 95% CI 0.95 to 1.38; 50 women; 1 study; Analysis 17.1) and multiparous women (RR 1.24, 95% CI 0.80 to 1.93; 48 women; 1 study; Analysis 18.1) as the results for these outcomes were imprecise.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (Analysis 16.2), as events seem to occur infrequently after the use of both induction methods. Of the five studies included for this comparison, one study (217 women) reported on this outcome. No events of uterine hyperstimulation with FHR occurred in this study.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (average RR 0.97, 95% CI 0.71 to 1.33; 862 women; 5 studies; Analysis 16.3). Also, there was moderate heterogeneity for this outcome (Chi² = 6.99, df = 4 (P = 0.14); I² = 43%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of concealment or attrition bias (Ahmed 2016), did not change the effect observed, nor did it lower heterogeneity (average RR 0.92, 95% CI 0.65 to 1.32; 788 women; 5 studies; I² = 50%).

The same result was seen on parity subgroup comparisons for primiparous women (average RR 1.30, 95% CI 0.76 to 2.22; 374 women; 4 studies; Analysis 17.2) and multiparous women (RR 0.74, 95% CI 0.30 to 1.84; 186 women; 2 studies; Analysis 18.2). Furthermore, for the primiparous group, there was also substantial heterogeneity (Tau² = 0.18; Chi² = 7.96, df = 3 (P = 0.05); I² = 62%).

Serious neonatal morbidity or perinatal death

Not reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 16.4). Of the five studies included for this comparison, one study (217 women) reported on this composite outcome. No events of serious maternal morbidity or death occurred in this study.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

There probably is little or no difference in oxytocin augmentation between both induction methods (RR 0.94, 95% CI 0.82 to 1.08; 278 women; 2 studies; Analysis 16.5).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes (Analysis 16.6), although events seem to occur infrequently after the use of both induction methods. Of the five studies included for this comparison, one study (217 women) reported on this outcome. No events of uterine hyperstimulation without FHR occurred in this study.

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 16.7). Of the five studies included for this comparison, one study (217 women) reported on this outcome. No events of uterine rupture occurred in this study.

Epidural analgesia

There probably is little or no difference in epidural analgesia between both induction methods (RR 0.93, 95% CI 0.83 to 1.03; 608 women; 3 studies; Analysis 16.8).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.86, 95% CI 0.61 to 1.20; 690 women; 3 studies; Analysis 16.9).

Meconium‐stained liquor

A single balloon may reduce the risk of meconium‐stained liquor when compared to a double balloon (RR 0.40, 95% CI 0.15 to 1.04; 98 women; 1 study; Analysis 16.10). However, the result is still too imprecise to make a valid judgement on this outcome.

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 0.84, 95% CI 0.25 to 2.79; 608 women; 3 studies; Analysis 16.11).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both induction methods (RR 1.67, 95% CI 0.71 to 3.93; 391 women; 2 studies; Analysis 16.12).

Neonatal encephalopathy

Not reported.

Perinatal death

Not reported.

Disability in childhood

Not reported.

Maternal side effects (all)

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects: pain after insertion

It is uncertain whether there is a difference in pain after insertion of the catheter between both induction methods (RR 0.67, 95% CI 0.20 to 2.17; 74 women; 1 study; Analysis 16.13).

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 0.83, 95% CI 0.27 to 2.52; 291 women; 2 studies; Analysis 16.14).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

It is uncertain whether there is a difference in maternal fever during labour between both induction methods (average RR 0.61, 95% CI 0.16 to 2.34; 584 women; 3 studies; Analysis 16.15). Also, there was substantial heterogeneity for this outcome (Chi² = 2.85, df = 1 (P = 0.09); I² = 65%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Ahmed 2016), did not alter the result, nor did it lower heterogeneity (average RR 0.61, 95% CI 0.16 to 2.34; 510 women; 2 studies; I² = 65%).

Antibiotics during labour

It is uncertain whether there is a difference in antibiotics during labour between both induction methods (RR 0.97, 95% CI 0.61 to 1.56; 217 women; 1 study; Analysis 16.16).

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 1.56, 95% CI 0.47 to 5.20; 98 women;1 study; Analysis 16.17).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 1.95, 95% CI 0.18 to 21.14; 217 women; 1 study; Analysis 16.18).

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated (RR 0.98, 95% CI 0.70 to 1.36; 682 women; 4 studies; Analysis 16.19).

Umbilical artery pH < 7.10

It is uncertain whether there is a difference in umbilical artery pH less than 7.10 directly postpartum between both induction methods (RR 0.42, 95% CI 0.11 to 1.57; 217 women; 1 study; Analysis 16.20).

Laminaria tent versus vaginal prostaglandin E2 (five trials involving 263 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

Not reported.

Uterine hyperstimulation with FHR changes

A laminaria tent probably reduces the risk of uterine hyperstimulation with FHR changes when compared to vaginal prostaglandin E2 (RR 0.11, 95% CI 0.02 to 0.60; 188 women; 3 studies; Analysis 19.1), the absolute effect being 118 fewer per 1000 deliveries.

For primiparous women, it is uncertain whether there is a difference in effect as the result of this outcome was imprecise (RR 0.33, 95% CI 0.01 to 7.95; 80 women; 1 study; Analysis 20.1). For multiparous women, this outcome was not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (RR 0.91, 95% CI 0.56 to 1.48; 263 women; 5 studies; Analysis 19.2).

The same result was seen on parity subgroup comparisons for primiparous women (average RR 1.07, 95% CI 0.24 to 4.89; 90 women; 2 studies; Analysis 20.2) and multiparous women (RR 0.50, 95% CI 0.06 to 3.91; 10 women; 1 study; Analysis 21.1). Furthermore, for the primiparous group, there was also substantial heterogeneity (Chi² = 2.25, df = 1 (P = 0.13); I² = 56%).

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (Analysis 19.3). Of the five studies included for this comparison, one study (80 women) reported on this composite outcome. No events of neonatal morbidity or perinatal death occurred in this study.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 19.4). Of the five studies included for this comparison, one study (28 women) reported on this composite outcome. No events of serious maternal morbidity or death occurred in this study.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

Not reported.

Uterine hyperstimulation without FHR changes

A laminaria tent may reduce the risk of uterine hyperstimulation without FHR changes when compared to vaginal PGE2 (RR 0.22, 95% CI 0.09 to 0.49; 180 women; 3 studies; Analysis 19.5).

Uterine rupture

Not reported.

Epidural analgesia

It is uncertain whether there is a difference in epidural analgesia between both induction methods (RR 0.91, 95% CI 0.74 to 1.13; 80 women; 1 study; Analysis 19.6).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.71, 95% CI 0.43 to 1.17; 80 women; 1 study; Analysis 19.7).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.14, 95% CI 0.01 to 2.68; 80 women; 1 study; Analysis 19.8).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (Analysis 19.9). Of the five studies included for this comparison, two studies (160 women) reported on this outcome. No events of Apgar scores less than seven at five minutes occurred in these studies.

Neonatal intensive care unit admission

Not reported.

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both induction methods (Analysis 19.10). Of the five studies included for this comparison, one study (80 women) reported on this outcome. No events of perinatal deaths occurred in this study.

Disability in childhood

Not reported.

Maternal side effects (all)

It is uncertain whether there is a difference in maternal side effects between both induction methods (RR 0.29, 95% CI 0.01 to 6.60; 28 women; 1 study; Analysis 19.11).

Maternal nausea

It is uncertain whether there is a difference in maternal nausea between both induction methods (RR 0.29, 95% CI 0.01 to 6.60; 28 women; 1 study; Analysis 19.12).

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

Not reported.

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

Not reported.

Endometritis

Not reported.

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 0.62, 95% CI 0.34 to 1.15; 188 women; 3 studies; Analysis 19.13).

Umbilical artery pH < 7.10

Not reported.

Laminaria tent versus cervical prostaglandin E2 (five trials involving 920 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

Not reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between induction of labour with a laminaria tent and cervical PGE2 (RR 0.17, 95% CI 0.02 to 1.42; 350 women; 2 studies; Analysis 22.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (RR 1.16, 95% CI 0.93 to 1.45; 920 women; 5 studies; Analysis 22.2).

The same results were seen on parity subgroup comparisons for primiparous women (RR 1.15, 95% CI 0.62 to 2.13; 116 women; 1 study; Analysis 23.1) and multiparous women (RR 1.28, 95% CI 0.45 to 3.65; 69 women; 1 study; Analysis 24.1).

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 3.16, 95% CI 0.13 to 76.70; 185 women; 1 study; Analysis 22.3). One event, a case of perinatal death, was reported in the laminaria group. No events occurred in the cervical PGE2 group.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (RR 0.35, 95% CI 0.01 to 8.52; 185 women; 1 study; Analysis 22.4). No events occurred in the laminaria group. One event, a uterine rupture, was reported in the cervical PGE2 group.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

It is uncertain whether there is a difference in an unfavourable cervix after 24 hours between both induction methods (average RR 0.46, 95% CI 0.11 to 1.96; 218 women; 2 studies; Analysis 22.5). Also, there was substantial heterogeneity for this outcome (Tau² = 0.62; Chi² = 1.98, df = 1 (P = 0.16); I² = 50%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Roztocil 1998), did not alter the result (RR 0.16, 95% CI 0.02 to 1.24; 53 women; 1 study; I² = 0%).

Oxytocin augmentation

A laminaria tent probably increases the risk of oxytocin augmentation when compared to cervical PGE2 (RR 1.41, 95% CI 1.21 to 1.64; 185 women; 1 study; Analysis 22.6).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (RR 0.17, 95% CI 0.02 to 1.36; 601 women; 2 studies; Analysis 22.7).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (RR 0.35, 95% CI 0.01 to 8.52; 185 women; 1 study; Analysis 22.8). One study reported on this outcome in which one uterine rupture occurred in the PGE2 group. No uterine ruptures were seen in the laminaria group.

Epidural analgesia

Not reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 1.05, 95% CI 0.65 to 1.69; 424 women; 3 studies; Analysis 22.9).

Meconium‐stained liquor

Not reported.

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 5.28, 95% CI 0.63 to 44.30; 185 women; 1 study; Analysis 22.10).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both induction methods (RR 1.58, 95% CI 0.58 to 4.33; 259 women; 2 studies; Analysis 22.11).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both induction methods (RR 3.16, 95% CI 0.13 to 76.70; 185 women; 1 study; Analysis 22.12). One study reported on this outcome, in which one perinatal death occurred in the laminaria group. No perinatal death were seen in the cervical PGE2 group.

Disability in childhood

Not reported.

Maternal side effects (all)

It is uncertain whether there is a difference in maternal side effects between both induction methods (RR 0.20, 95% CI 0.01 to 4.15; 165 women; 1 study; Analysis 22.13). The one study included for this outcome reported on gastro‐intestinal symptoms without specifying what the symptoms were.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 1.14, 95% CI 0.46 to 2.81; 239 women; 2 studies; Analysis 22.14).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 3.17, 95% CI 0.35 to 29.06; 74 women; 1 study; Analysis 22.15).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (average RR 0.30, 95% CI 0.08 to 1.09; 490 women; 2 studies; Analysis 22.16). Also, there was substantial heterogeneity for this outcome (Tau² = 0.54; Chi² = 2.54, df = 1 (P = 0.11); I² = 61%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Krammer 1995a), did not alter the result (RR 0.63, 95% CI 0.16 to 2.46; 74 women; 1 study; I² = 0%).

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 0.44, 95% CI 0.07 to 2.90; 128 women; 2 studies; Analysis 22.17).

Umbilical artery pH < 7.10

Not reported.

Laminaria tent versus oxytocin (two trials involving 73 women)

The only outcomes of interest reported for this comparison were caesarean section and fetal distress. Other outcomes were not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between induction of labour with a laminaria tent and oxytocin (RR 0.83, 95% CI 0.36 to 1.89; 73 women; 2 studies; Analysis 25.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 2.69, 95% CI 0.11 to 63.18; 53 women; 1 study; Analysis 25.2).

Laminaria tent versus amniotomy (one trial involving 20 women)

The only outcome of interest reported for this comparison was caesarean section. Other outcomes were not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between induction of labour with a laminaria tent compared to amniotomy (RR 0.75, 95% CI 0.22 to 2.52; 20 women; 1 study; Analysis 26.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Laminaria tent versus other hygroscopic dilators (one trial involving 41 women)

The only outcome of interest reported for this comparison was caesarean section. Other outcomes were not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between induction of labour with a laminaria tent and other hygroscopic dilators (RR 1.70, 95% CI 0.44 to 6.66; 41 women; 1 study; Analysis 27.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Extra amniotic saline infusion (EASI) versus vaginal prostaglandin E2 (two trials involving 221 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

EASI probably increases the risk of a vaginal delivery not achieved within 24 hours when compared to vaginal PGE2 (RR 1.74, 95% CI 1.21 to 2.49; 109 women; 1 study; Analysis 28.1).

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (RR 0.23, 95% CI 0.03 to 2.07; 221 women; 2 studies; Analysis 28.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (average RR 1.35, 95% CI 0.94 to 1.96; 221 women; 2 studies; Analysis 28.3). Also, there was substantial heterogeneity for this outcome (Chi² = 5.24, df = 1 (P = 0.02); I² = 81%). No sensitivity analysis could be done as both included studies were assessed as having a potentially higher risk of allocation or attrition bias.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

Not reported.

Serious maternal morbidity or death

Not reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

EASI may increase the risk of oxytocin augmentation when compared to vaginal PGE2 (RR 12.71, 95% CI 3.20 to 50.57; 109 women; 1 study; Analysis 28.4).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (RR 0.23, 95% CI 0.03 to 2.07; 221 women; 2 studies; Analysis 28.5).

Uterine rupture

Not reported.

Epidural analgesia

There may be little or no difference in epidural analgesia between both induction methods (RR 1.00, 95% CI 0.97 to 1.04; 112 women; 1 study; Analysis 28.6).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.58, 95% CI 0.30 to 1.14; 109 women; 1 study; Analysis 28.7).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 3.00, 95% CI 0.12 to 72.10; 112 women; 1 study; Analysis 28.8).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 4.25, 95% CI 0.21 to 86.51; 109 women; 1 study; Analysis 28.9).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both induction methods (RR 1.50, 95% CI 0.45 to 5.03; 112 women; 1 study; Analysis 28.10).

Neonatal encephalopathy

Not reported.

Perinatal death

Not reported.

Disability in childhood

Not reported.

Maternal side effects (all)

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

Not reported.

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

It is uncertain whether there is a difference in women not being satisfied between both induction methods (RR 0.56, 95% CI 0.10 to 3.25; 109 women; 1 study; Analysis 28.11). For this outcome, women in the included study were asked to comment on the induction method, for which they could choose between recommendable, satisfactory and unsatisfactory.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

Not reported.

Endometritis

Not reported.

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 1.20, 95% CI 0.39 to 3.71; 112 women; 1 study; Analysis 28.12).

Umbilical artery pH < 7.10

Not reported.

Extra amniotic saline infusion versus cervical prostaglandin E2 (two trials involving 155 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

Not reported.

Uterine hyperstimulation with FHR changes

Not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (average RR 0.73, 95% CI 0.10 to 5.12; 155 women; 2 studies; Analysis 29.1). Also, there was substantial heterogeneity for this outcome (Tau² = 1.60; Chi² = 5.11, df = 1 (P = 0.02); I² = 80%). As the results for both included studies show no overlap of CI, this makes the pooled result for this outcome less meaningful. No sensitivity analysis was performed as no potential high‐risk studies were included for this outcome.

The same result was seen on a subgroup comparison for primiparous women (RR 0.25, 95% CI 0.06 to 1.09; 70 women; 1 study; Analysis 30.1). For multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

Not reported.

Serious maternal morbidity or death

Not reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

EASI may reduce the risk of an unfavourable cervix after 24 hours when compared to cervical PGE2 (RR 0.06, 95% CI 0.00 to 0.97; 85 women; 1 study; Analysis 29.2).

Oxytocin augmentation

It is uncertain whether there is a difference in oxytocin augmentation between both induction methods (RR 1.10, 95% CI 0.54 to 2.25; 70 women; 1 study; Analysis 29.3).

Uterine hyperstimulation without FHR changes

Not reported.

Uterine rupture

Not reported.

Epidural analgesia

Not reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.33, 95% CI 0.04 to 3.01; 85 women; 1 study; Analysis 29.4).

Meconium‐stained liquor

Not reported.

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (Analysis 29.5). One study (85 women) pre‐specified this outcome in which no Apgar scores less than seven after five minutes were reported.

Neonatal intensive care unit admission

Not reported.

Neonatal encephalopathy

Not reported.

Perinatal death

Not reported.

Disability in childhood

Not reported.

Maternal side effects (all)

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

Not reported.

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

Not reported.

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (Analysis 29.6). One study (85 women) pre‐specified this outcome in which no cases of endometritis were reported.

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 0.29, 95% CI 0.06 to 1.28; 70 women; 1 study; Analysis 29.7).

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone (eight trials involving 639 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

It is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a mechanical method combined with PGE2 and PGE2 alone (RR 0.84, 95% CI 0.53 to 1.33; 39 women; 1 study; Analysis 31.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (RR 0.26, 95% CI 0.01 to 5.12; 122 women; 2 studies; Analysis 31.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (average RR 0.96, 95% CI 0.66 to 1.40; 517 women; 7 studies; Analysis 31.3). Also, there was moderate heterogeneity for this outcome (Tau² = 0.11; Chi² = 11.16, df = 6 (P = 0.08); I² = 46%).

A sensitivity analysis, after eliminating three trials assessed as having a potentially higher risk of allocation or attrition bias (Browne 2011; Lyndrup 1989; Turnquest 1997), did not alter the result nor did it lower heterogeneity (average RR 1.02, 95% CI 0.56 to 1.84; 364 women; 4 studies; I² = 70%).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

Not reported.

Serious maternal morbidity or death

Not reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

A mechanical method combined with PGE2 may reduce the risk of an unfavourable cervix after 24 hours when compared to PGE2 alone (RR 0.52, 95% CI 0.31 to 0.85; 122 women; 1 study; Analysis 31.4).

Oxytocin augmentation

It is uncertain whether there is a difference in oxytocin augmentation between both induction methods (RR 0.95, 95% CI 0.64 to 1.41; 44 women; 1 study; Analysis 31.5).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (Analysis 31.6). Of the eight studies included for this comparison, three studies (239 women) pre‐specified this outcome. No events of uterine hyperstimulation without FHR changes occurred in these studies.

Uterine rupture

Not reported.

Epidural analgesia

There may be little or no difference in epidural analgesia during labour between both induction methods (RR 0.98, 95% CI 0.77 to 1.24; 39 women; 1 study; Analysis 31.7).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.56, 95% CI 0.22 to 1.45; 78 women; 2 studies; Analysis 31.8).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.97, 95% CI 0.33 to 2.83; 120 women; 1 study; Analysis 31.9).

Apgar score less than seven at five minutes

Not reported.

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both methods (RR 0.26, 95% CI 0.01 to 5.12; 44 women; 1 study; Analysis 31.10).

Neonatal encephalopathy

Not reported.

Perinatal death

Not reported.

Disability in childhood

Not reported.

Maternal side effects

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (Analysis 31.11). Of the eight studies included for this comparison, one study (39 women) pre‐specified this outcome. No events of postpartum haemorrhage occurred in this study.

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 1.56, 95% CI 0.45 to 5.45; 122 women; 2 studies; Analysis 31.12).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 1.07, 95% CI 0.41 to 2.78; 237 women; 3 studies; Analysis 31.13).

Fetal distress

It is uncertain whether there is a difference fetal distress for which a caesarean section is indicated between both induction methods (RR 2.28, 95% CI 0.54 to 9.69; 140 women; 2 studies; Analysis 31.14).

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and prostaglandin E2 versus low‐dose misoprostol alone (one trial involving 127 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

A mechanical method combined with PGE2 probably reduces the risk of a vaginal delivery not achieved within 24 hours when compared to misoprostol (RR 0.32, 95% CI 0.12 to 0.82; 127 women; 1 study; Analysis 32.1). the absolute effect being 165 less per 1000 deliveries.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

Not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (RR 1.09, 95% CI 0.58 to 2.04; 127 women; 1 study; Analysis 32.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 0.19, 95% CI 0.01 to 3.90; 127 women; 1 study; Analysis 32.3). Two events occurred in the misoprostol group, both being cases of perinatal death.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

Not reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

A mechanical method combined with PGE2 probably reduces the risk of an unfavourable cervix after 24 hours when compared to misoprostol (RR 0.41, 95% CI 0.25 to 0.67; 127 women; 1 study; Analysis 32.4).

Oxytocin augmentation

A mechanical method combined with PGE2 probably slightly increases the risk of oxytocin augmentation when compared to misoprostol (RR 1.21, 95% CI 1.01 to 1.46; 127; 1 study; Analysis 32.5).

Uterine hyperstimulation without FHR changes

A mechanical method combined with PGE2 probably increases the risk of uterine hyperstimulation without FHR changes when compared to misoprostol (RR 4.05, 95% CI 1.44 to 11.38; 127; 1 study; Analysis 32.6).

Uterine rupture

Not reported.

Epidural analgesia

Not reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 1.26, 95% CI 0.77 to 2.04; 127 women; 1 study; Analysis 32.7).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.56, 95% CI 0.23 to 1.32; 127 women; 1 study; Analysis 32.8).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 1.91, 95% CI 0.18 to 20.51; 127 women; 1 study; Analysis 32.9).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both methods (RR 0.64, 95% CI 0.31 to 1.31; 127 women; 1 study; Analysis 32.10).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both methods (RR 0.19, 95% CI 0.01 to 3.90; 127 women; 1 study; Analysis 32.11). Two cases of neonatal death were reported by Perry 1998, both were born to women randomised to misoprostol. The authors describe that in both cases the neonates died as a result of complications of congenital malformations and were unrelated to the induction method.

Disability in childhood

Not reported.

Maternal side effects

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

Not reported.

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 1.91, 95% CI 0.18 to 20.51; 127 women; 1 study; Analysis 32.12).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 1.91, 95% CI 0.36 to 10.05; 127 women; 1 study; Analysis 32.13).

Fetal distress

Not reported.

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and prostaglandin E2 versus oxytocin alone (one trial involving 44 women)

The only outcomes of interest reported for this comparison were caesarean section, instrumental vaginal delivery and endometritis. Other outcomes were not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between induction of labour with a mechanical method combined with PGE2 versus oxytocin (RR 0.30, 95% CI 0.04 to 2.47; 44 women; 1 study; Analysis 33.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.60, 95% CI 0.12 to 2.94; 44 women; 1 study; Analysis 33.2).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 3.57, 95% CI 0.15 to 83.14; 44 women; 1 study; Analysis 33.3).

Any mechanical method and low‐dose misoprostol versus prostaglandin E2 alone (one trial involving 350 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

It is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a mechanical method combined with misoprostol and prostaglandin E2 (RR 1.14, 95% CI 0.89 to 1.46; 350 women; 1 study; Analysis 34.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (RR 0.75, 95% CI 0.27 to 2.13; 327 women; 1 study; Analysis 34.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (RR 0.85, 95% CI 0.57 to 1.25; 350 women; 1 study; Analysis 34.3).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 2.04, 95% CI 0.19 to 22.24; 345 women; 1 study; Analysis 34.4).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 34.5). No events of maternal morbidity or death occurred in the one included study (350 women).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

A mechanical method combined with misoprostol probably reduces the risk of oxytocin augmentation when compared to PGE2 (RR 0.54, 95% CI 0.34 to 0.86; 350 women; 1 study; Analysis 34.6).

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (RR 0.54, 95% CI 0.22 to 1.32; 327 women; 1 study; Analysis 34.7).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 34.8). No events of uterine rupture occurred in the one included study (350 women).

Epidural analgesia

Not reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 1.01, 95% CI 0.26 to 3.98; 350 women; 1 study; Analysis 34.9).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 1.15, 95% CI 0.60 to 2.23; 339 women; 1 study; Analysis 34.10).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 0.68, 95% CI 0.25 to 1.88; 346 women; 1 study; Analysis 34.11).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both methods (RR 0.68, 95% CI 0.12 to 4.03; 346 women; 1 study; Analysis 34.12).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both induction methods (RR 1.02, 95% CI 0.06 to 16.14; 345 women; 1 study; Analysis 34.13). Two cases of perinatal death were reported by Matonhodze 2003, one in each group. No further information was given on timing or cause of the demise.

Disability in childhood

Not reported.

Maternal side effects

It is uncertain whether there is a difference in maternal side effects between both induction methods (RR 1.16, 95% CI 0.95 to 1.43; 314 women; 1 study; Analysis 34.14).

Maternal nausea

A mechanical method combined with misoprostol may increase the risk of maternal nausea when compared to PGE2 (RR 1.65, 95% CI 0.98 to 2.79; 300 women; 1 study; Analysis 34.15). However, the result is still too imprecise to make a valid judgement on this outcome.

Maternal vomiting

Not reported.

Maternal diarrhoea

A mechanical method combined with misoprostol probably increases the risk of maternal diarrhoea when compared to PGE2 (RR 3.72, 95% CI 1.53 to 9.00; 313 women; 1 study; Analysis 34.16).

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 0.98, 95% CI 0.67 to 1.41; 348 women; 1 study; Analysis 34.17).

Serious maternal complications

It is uncertain whether there is a difference in serious maternal complications between both induction methods (Analysis 34.18). One study (350 women) was included for this outcome in which no cases of septicaemia or intensive care unit admission were reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

It is uncertain whether there is a difference in maternal fever during labour between both induction methods (RR 1.53, 95% CI 0.26 to 9.02; 347 women; 1 study; Analysis 34.19).

Antibiotics during labour

Not reported.

Chorioamnionitis

Not reported.

Endometritis

Not reported.

Fetal distress

Not reported.

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and low dose misoprostol versus misoprostol alone (six trials involving 1104 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

It is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between any mechanical method combined with misoprostol and misoprostol alone (RR 1.14 95% CI 0.89 to 1.46; 350 women; 1 study; Analysis 35.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (average RR 0.54, 95% CI 0.20 to 1.45; 707 women; 4 studies; Analysis 35.2). Also, there was substantial heterogeneity for this outcome (Tau² = 0.57; Chi² = 7.40, df = 2 (P = 0.02); I² = 73%). No sensitivity analysis was performed as no potential high‐risk studies were included for this outcome.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

There probably is little or no difference in caesarean sections between both induction methods (RR 0.96, 95% CI 0.79 to 1.17; 1104 women; 6 studies; Analysis 35.3).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 1.25, 95% CI 0.34 to 4.55; 487 women; 2 studies; Analysis 35.4).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 35.5). Of the six studies included for this comparison, two studies (490 women) reported on this composite outcome. No events of serious maternal morbidity or death occurred in these studies.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

A mechanical method combined with misoprostol probably reduces the risk of an unfavourable cervix after 24 hours when compared to misoprostol alone (RR 0.27, 95% CI 0.08 to 0.94; 140 women; 1 study; Analysis 35.6).

Oxytocin augmentation

It is uncertain whether there is a difference in oxytocin augmentation between both induction methods (average RR 0.98, 95% CI 0.66 to 1.48; 733 women; 4 studies; Analysis 35.7). Also, there was substantial heterogeneity for this outcome (Tau² = 0.13; Chi² = 16.69, df = 3 (P = 0.0008); I² = 82%).

Uterine hyperstimulation without FHR changes

A mechanical method combined with misoprostol probably reduces the risk of uterine hyperstimulation without FHR changes when compared to misoprostol alone (RR 0.50, 95% CI 0.26 to 0.94; 664 women; 3 studies; Analysis 35.8).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 35.9). Of the six studies included for this comparison, two studies (490 women) reported on this outcome. No events of uterine rupture occurred in one of these studies.

Epidural analgesia

There may be little or no difference in epidural analgesia between both induction methods (average RR 1.00, 95% CI 0.91 to 1.10; 443 women; 3 studies; Analysis 35.10), although there was moderate heterogeneity for this outcome (Tau² = 0.00; Chi² = 3.52, df = 2 (P = 0.17); 43%).

No sensitivity analysis was performed as no potential high‐risk studies were included for this outcome.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.93, 95% CI 0.58 to 1.51; 676 women; 3 studies; Analysis 35.11).

Meconium‐stained liquor

it is uncertain whether there is difference in meconium‐stained liquor between both induction methods (average RR 0.55, 95% CI 0.26 to 1.14; 925 women; 5 studies Analysis 35.12). Also, there was substantial heterogeneity for this outcome (Tau² = 0.43; Chi² = 11.06, df = 4 (P = 0.03); I² = 64%).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar score less than seven at five minutes between both induction methods (RR 1.10, 95% CI 0.50 to 2.43; 484 women; 2 studies; Analysis 35.13).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admission between both methods (RR 0.79, 95% CI 0.41 to 1.55; 928 women; 5 studies; Analysis 35.14).

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is difference in perinatal death between both induction methods (RR 3.09, 95% CI 0.13 to 75.26; 347 women; 1 study; Analysis 35.15). One case of perinatal death was reported by Matonhodze 2003, which occurred in the combined method group. No further information was given on timing or cause of the demise.

Disability in childhood

Not reported.

Maternal side effects (all)

It is uncertain whether there is a difference in maternal side effects between both induction methods (RR 1.06, 95% CI 0.87 to 1.30; 300 women; 1 study; Analysis 35.16).

Maternal nausea

It is uncertain whether there is a difference in maternal nausea between both induction methods (RR 1.37, 95% CI 0.84 to 2.23; 300 women; study; Analysis 35.17).

Maternal vomiting

Not reported.

Maternal diarrhoea

A mechanical method combined with misoprostol probably increases the risk of maternal diarrhoea when compared to misoprostol alone (RR 3.38, 95% CI 1.40 to 8.17; 298 women; 1 study; Analysis 35.18 ).

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is difference in postpartum haemorrhage between both induction methods (RR 0.93, 95% CI 0.65 to 1.33; 466 women; 2 studies; Analysis 35.19).

Serious maternal complications

It is uncertain whether there is a difference in serious maternal complications between both induction methods (Analysis 35.20). One study (350 women) was included for this outcome in which no cases of septicaemia or intensive care unit admissions were seen.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 0.63, 95% CI 0.28 to 1.38; 443 women; 3 studies; Analysis 35.21).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 0.54, 95% CI 0.05 to 5.84; 117 women; 1 study; Analysis 35.22).

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 0.94, 95% CI 0.61 to 1.46; 466 women; 3 studies; Analysis 35.23).

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and oxytocin versus prostaglandin E2 alone (four trials involving 713 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

Not reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between a mechanical method combined with oxytocin and PGE2 (RR 1.48, 95% CI 0.55 to 3.95; 151 women; 1 study; Analysis 36.1).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (RR 0.93, 95% CI 0.72 to 1.20; 713 women; 4 studies; Analysis 36.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious neonatal morbidity or perinatal death

Not reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 36.3). One study (200 women) was included for this composite outcome in which no events of maternal morbidity or death occurred.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

A mechanical method combined with oxytocin probably increases the risk of oxytocin augmentation when compared to PGE2 (RR 2.48, 95% CI 1.95 to 3.15; 200 women; 1 study; Analysis 36.4).

Uterine hyperstimulation without FHR changes

A mechanical method combined with oxytocin probably increases the risk of uterine hyperstimulation without FHR changes when compared to PGE2 (RR 2.19, 95% CI 1.39 to 3.46; 151 women; 1 study; Analysis 36.5).

Uterine rupture

Not reported.

Epidural analgesia

Not reported.

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.35, 95% CI 0.08 to 1.58; 41 women; 1 study; Analysis 36.6).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 1.13, 95% CI 0.43 to 2.95; 151 women; 1 study; Analysis 36.7).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 2.96, 95% CI 0.12 to 71.55; 151 women; 1 study; Analysis 36.8).

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both methods (RR 0.85, 95% CI 0.30 to 2.40; 151 women; 1 study; Analysis 36.9).

Neonatal encephalopathy

Not reported.

Perinatal death

Not reported.

Disability in childhood

Not reported.

Maternal side effects

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 0.14, 95% CI 0.01 to 2.68; 151 women; 1 study; Analysis 36.10).

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

Not reported.

Chorioamnionitis

Not reported.

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (Analysis 36.11). One study (41 women) reported on this outcome. No events of endometritis occurred in this study.

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (average RR 0.97, 95% CI 0.61 to 1.56; 498 women; 3 studies; Analysis 36.12). Also, there was moderate heterogeneity for this outcome (Tau² = 0.06; Chi² = 2.93, df = 2 (P = 0.23); I² = 32%).

No sensitivity analysis was performed as no potential high‐risk studies were included for this outcome.

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and oxytocin versus misoprostol alone (six trials involving 1779 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

A mechanical method combined with oxytocin probably reduces the risk of a vaginal delivery not being achieved within 24 hours when compared to misoprostol (RR 0.48, 95% CI 0.37 to 0.63; 362 women; 2 studies; Analysis 37.1), the absolute effect being 285 fewer per 1000 deliveries.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes between both induction methods (RR 0.43, 95% CI 0.17 to 1.11; 1463 women; 3 studies; Analysis 37.2).

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Caesarean section

There probably is little or difference in caesarean sections between both induction methods (RR 0.95, 95% CI 0.80 to 1.12; 1779 women; 5 studies; Analysis 37.3).

For the subgroup of primiparous women, no outcomes were reported. For multiparous women, it is uncertain whether there is a difference in caesarean sections between both induction methods (RR 0.45, 95% CI 0.19 to 1.11; 136 women; 1 study; Analysis 38.1).

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 0.82, 95% CI 0.18 to 3.65;1263 women; 2 studies; Analysis 37.4). All the events included for this composite outcome were cases of neonatal death.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

Not reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

It is uncertain whether there is a difference in oxytocin augmentation between both induction methods (average RR 3.89, 95% CI 0.70 to 21.72; 336 women; 2 studies; Analysis 37.5). Also, there was substantial heterogeneity for this outcome (Tau² = 1.46; Chi² = 18.47, df = 1 (P < 0.0001); I² = 95%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Garba 2016), changed the result in favour of misoprostol as it showed a mechanical method combined with oxytocin may increase the risk of oxytocin augmentation (RR 1.91, 95% CI 1.59 to 2.31; 200 women; 1 study).

Uterine hyperstimulation without FHR changes

A mechanical method combined with oxytocin probably reduces the risk of uterine hyperstimulation without FHR changes when compared to misoprostol (RR 0.52, 95% CI 0.30 to 0.92; 498 women; 3 studies; Analysis 37.6).

Uterine rupture

Not reported.

Epidural analgesia

It is uncertain whether there is a difference in epidural analgesia between both induction methods (RR 1.07, 95% CI 0.90 to 1.27; 162 women; 1 study; Analysis 37.7).

Instrumental vaginal delivery

Not reported.

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.72, 95% CI 0.43 to 1.19; 362 women; 2 studies; Analysis 37.8).

Apgar score less than seven at five minutes

It is uncertain whether there is a difference in Apgar scores less than seven at five minutes between both induction methods (RR 0.95, 95% CI 0.20 to 4.58; 162 women; 1 study; Analysis 37.9).

Neonatal intensive care unit admission

A mechanical method combined with oxytocin probably reduces the risk of a NICU admission when compared to misoprostol (RR 0.66, 95% CI 0.49 to 0.90; 1599 women; 4 studies; Analysis 37.10), the absolute effect being 37 fewer NICU admissions per 1000 deliveries.

Neonatal encephalopathy

Not reported.

Perinatal death

It is uncertain whether there is a difference in perinatal death between both induction methods (RR 0.82, 95% CI 0.18 to 3.65; 1263 women; 2 studies; Analysis 37.11). Perinatal death occurred in one of the included studies (Gilson 2017). All were cases of neonatal death. No further information was given on cause of the demise.

Disability in childhood

Not reported.

Maternal side effects

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

Not reported.

Serious maternal complications

Not reported.

Maternal death

Not reported.

Woman not satisfied

A mechanical method combined with oxytocin may increase the risk of women not being satisfied when compared to misoprostol (RR 1.68, 95% CI 1.47 to 1.93; 866 women; 1 study; Analysis 37.12), the absolute effect being 260 more women not satisfied per 1000 deliveries. For this outcome, women in the study of Gilson 2017 were asked if they would choose the same method again if induction of labour was needed in a future pregnancy.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

A mechanical method combined with oxytocin may reduce the risk of maternal fever during labour when compared to misoprostol (RR 0.13, 95% CI 0.04 to 0.50; 298 women; 2 studies; Analysis 37.13).

Antibiotics during labour

Not reported.

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (RR 0.65, 95% CI 0.32 to 1.31; 200 women; 1 study; Analysis 37.14).

Endometritis

Not reported.

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 0.55, 95% CI 0.25 to 1.21; 362 women; 2 studies; Analysis 37.15).

Umbilical artery pH < 7.10

Not reported.

Any mechanical method and oxytocin versus oxytocin alone (six trials involving 718 women)

Primary outcomes

Vaginal delivery not achieved within 24 hours

It is uncertain whether there is a difference in a vaginal delivery not being achieved within 24 hours between induction of labour with a mechanical method combined with oxytocin and oxytocin alone (average RR 0.71, 95% CI 0.21 to 2.40; 321 women; 2 studies; Analysis 39.1). Also, there was substantial heterogeneity for this outcome (Tau² = 0.72; Chi² = 19.17, df = 1 (P,0.0001); I² = 95%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Mackeen 2018), changed the result in favour of a mechanical method combined with oxytocin as it showed it may reduce the risk of vaginal delivery not being achieved within 24 hours (RR 0.39, 95% CI 0.27 to 0.55; 120 women; 1 study), the absolute effect being 550 fewer per 1000 deliveries.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Uterine hyperstimulation with FHR changes

Not reported.

Caesarean section

It is uncertain whether there is a difference in caesarean sections between both induction methods (average RR 0.68, 95% CI 0.39 to 1.20; 718 women; 6 studies; Analysis 39.2). Also, there was substantial heterogeneity for this outcome (Tau² = 0.32; Chi² = 17.15, df = 5 (P = 0.004); I² = 71%).

A sensitivity analysis, after eliminating the three trials assessed as having a potentially higher risk of allocation or attrition bias (Lyndrup 1989; Mackeen 2018; Tita 2006), did not alter the result nor did it lower heterogeneity (average RR 0.57, 95% CI 0.21 to 1.52; 319 women; 3 studies; I² = 82%).

Serious neonatal morbidity or perinatal death

It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death between both induction methods (RR 0.71, 95% CI 0.12 to 4.13; 321 women; 2 studies; Analysis 39.3). All the events included for this composite outcome were cases of asphyxia.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Serious maternal morbidity or death

It is uncertain whether there is a difference in serious maternal morbidity or death between both induction methods (Analysis 39.4). Of the six included studies for this comparison, two studies (321 women) reported on this composite outcome. No events of maternal morbidity or death occurred in these studies.

For the subgroups of primiparous and multiparous women, no outcomes were reported.

Secondary outcomes

Cervix unfavourable/unchanged after 24 hours

Not reported.

Oxytocin augmentation

Not reported.

Uterine hyperstimulation without FHR changes

It is uncertain whether there is a difference in uterine hyperstimulation without FHR changes between both induction methods (RR 0.85, 95% CI 0.34 to 2.09; 199 women; 2 studies; Analysis 39.5).

Uterine rupture

It is uncertain whether there is a difference in uterine rupture between both induction methods (Analysis 39.6). Of the six included studies for this comparison, one study (120 women) reported on this outcome. No events of uterine rupture occurred in this study.

Epidural analgesia

There probably is little or no difference in epidural analgesia between both induction methods (RR 1.03, 95% CI 0.98 to 1.09; 127 women; 1 study; Analysis 39.7).

Instrumental vaginal delivery

It is uncertain whether there is a difference in instrumental vaginal deliveries between both induction methods (RR 0.99, 95% CI 0.48 to 2.02; 293 women; 3 studies; Analysis 39.8).

Meconium‐stained liquor

It is uncertain whether there is a difference in meconium‐stained liquor between both induction methods (RR 0.72, 95% CI 0.32 to 1.63; 319 women; 3 studies; Analysis 39.9).

Apgar score less than seven at five minutes

Not reported.

Neonatal intensive care unit admission

It is uncertain whether there is a difference in NICU admissions between both induction methods (RR 0.98, 95% CI 0.61 to 1.58; 400 women; 3 studies; Analysis 39.10).

Neonatal encephalopathy

Not reported.

Perinatal death

Not reported.

Disability in childhood

Not reported.

Maternal side effects

Not reported.

Maternal nausea

Not reported.

Maternal vomiting

Not reported.

Maternal diarrhoea

Not reported.

Other maternal side effects

Not reported.

Postpartum haemorrhage

It is uncertain whether there is a difference in postpartum haemorrhage between both induction methods (RR 1.18, 95% CI 0.44 to 3.18; 319 women; 3 studies; Analysis 39.11).

Serious maternal complications

It is uncertain whether there is a difference in serious maternal complications between both induction methods (Analysis 39.12). Of the six included studies for this comparison, one study (201 women) reported on maternal sepsis. No events occurred in this study.

Maternal death

Not reported.

Woman not satisfied

Not reported.

Caregiver not satisfied

Not reported.

Other outcomes (not pre‐specified)

Maternal fever during labour

Not reported.

Antibiotics during labour

It is uncertain whether there is a difference in antibiotics during labour between both induction methods (RR 2.32, 95% CI 0.82 to 6.55; 201 women; 1 study; Analysis 39.13).

Chorioamnionitis

It is uncertain whether there is a difference in chorioamnionitis between both induction methods (average RR 4.34, 95% CI 0.55 to 34.01; 328 women; 2 studies; Analysis 39.14). Also, there was moderate heterogeneity for this outcome (Tau² = 1.19; Chi² = 1.92, df = 1 (P = 0.17); I² = 48%).

A sensitivity analysis, after eliminating the one trial assessed as having a potentially higher risk of allocation or attrition bias (Mackeen 2018), did not alter the result (RR 2.16, 95% CI 0.57 to 8.28; 127 women; 1 study).

Endometritis

It is uncertain whether there is a difference in endometritis between both induction methods (RR 1.08, 95% CI 0.16 to 7.45; 374 women; 3 studies; Analysis 39.15).

Fetal distress

It is uncertain whether there is a difference in fetal distress for which a caesarean section is indicated between both induction methods (RR 1.37, 95% CI 0.68 to 2.77; 400 women; 3 studies; Analysis 39.16).

Umbilical artery pH < 7.10

Not reported.

Discussion

We set out to explore the effectiveness of mechanical methods for labour induction and their adverse effects for women and their babies in comparison to different pharmacological methods. We included a total of 112 studies, with 104 studies contributing data involving 22,055 women. This updated review now consists of 21 different comparisons (and 18 subgroup comparisons), where in most of the comparisons a mechanical method (balloon, laminaria or extra‐amniotic space infusion (EASI)) was compared with prostaglandin E2 (PGE2), misoprostol or oxytocin. We explored the combination of a mechanical method combined with a pharmacological method, as well as a single versus a double balloon.

Balloon

Balloon versus PGE2

A balloon catheter is probably as effective for inducing labour as vaginal PGE2, as there was little or no difference in a vaginal delivery not achieved within 24 hours (low‐quality evidence) and caesarean sections (moderate‐quality evidence) between both induction methods. However, oxytocin augmentation is probably more often required when labour is induced with a balloon catheter. As for perinatal outcomes, a balloon catheter appears to have a more favourable safety profile compared to vaginal PGE2, as it probably reduces the risk of uterine hyperstimulation with and without fetal heart rate (FHR) changes (moderate‐quality evidence), fetal distress for which a caesarean section is required and an umbilical artery pH less than 7.10. Also, a balloon catheter may slightly reduce the risk of a neonatal intensive care unit (NICU) admission (low‐quality evidence), although conventional statistical significance was not reached as the result was still too imprecise to make a valid judgement. Of note, a balloon catheter probably reduces the risk of serious neonatal morbidity or perinatal death (moderate‐risk evidence). However, this outcome should be interpreted with caution as only a few studies (eight out of 28 studies), reported on this composite outcome and therefore a bias for this result could exist. Most of the serious perinatal adverse events in this composite outcome were cases of perinatal asphyxia. Regarding our other main outcomes for this comparison, it was unclear if there is a difference in five‐minute Apgar score less than seven (low‐quality evidence) or serious maternal morbidity or death (very low‐quality evidence).

There was no evidence of a difference in outcomes between induction of labour with a balloon compared to cervical PGE2, although the risk of fetal distress for which a caesarean section is indicated is probably reduced when a balloon is used.

Balloon versus misoprostol

A balloon catheter may be less effective for induction of labour when compared to low‐dose oral misoprostol, as a balloon probably increases the risk of a vaginal delivery not achieved within 24 hours (moderate‐quality evidence), oxytocin augmentation and probably slightly increases the risk of a caesarean section (moderate‐quality evidence). Regarding safety outcomes for the neonate, which are hyperstimulation with (low‐quality evidence) and without FHR changes, serious neonatal morbidity or perinatal death (low‐quality evidence), NICU admission (low‐quality evidence), five‐minute Apgar score less than seven (low‐quality evidence), fetal distress and umbilical artery pH less than 7.10, it is unclear if there is a difference between both methods as results were too imprecise to make a valid judgement. This was also the case for the composite outcome serious maternal morbidity or death (very low‐quality evidence).

When compared to low‐dose vaginal misoprostol, a balloon catheter may increase the risk of a caesarean section and oxytocin augmentation (low‐quality evidence). However, there was substantial heterogeneity for both outcomes. For the outcome caesarean section, heterogeneity was not reduced after sensitivity analysis. The risk of hyperstimulation, with and without FHR changes, is probably reduced when a balloon catheter is used, as well as the risk of meconium‐stained liquor (moderate‐quality evidence). Regarding our other main outcomes for this comparison, it was unclear if there was a difference between serious neonatal morbidity or perinatal death (very low‐quality evidence), serious maternal morbidity or death (very low‐quality evidence), NICU admission (low‐quality evidence) and five‐minute Apgar score less than seven (low‐quality evidence) as these results were too imprecise to make a valid judgement.

Epidural analgesia is probably used slightly more after induction of labour with a balloon compared to low‐dose oral misoprostol, as well as vaginal misoprostol.

Balloon versus oxytocin

In women with an unfavourable cervix, cervical ripening with a balloon seems to be more effective than induction with oxytocin as it probably reduces the risk of caesarean section and the risk of fetal distress for which a caesarean section is indicated. For women with a previous caesarean section, a balloon catheter may slightly reduce the risk of a caesarean section when compared to oxytocin. However, the result is too imprecise to make a valid judgement on this outcome.

Single balloon versus double balloon

There is no evidence of benefit of a double balloon over a single balloon. There is little or no difference in vaginal deliveries not achieved within 24 hours and in oxytocin augmentation. No clear difference in caesarean section rate was seen between these induction methods. However, the result was still too imprecise to make a valid judgement. Hyperstimulation seems to occur infrequently with either balloons, as no events of uterine hyperstimulation with or without FHR changes were reported in the one study (217 women) which reported on these outcomes.

Laminaria tent

There was no evidence of a difference in outcomes between a laminaria tent compared to vaginal PGE2. However, results were too imprecise to make a valid judgement. Compared to cervical PGE2, a laminaria tent probably reduces the risk uterine hyperstimulation both with and without FHR changes.

EASI

Only a few small studies compared EASI with other methods. When compared to vaginal PGE2, EASI may increase the risk of a vaginal delivery not achieved within 24 hours and oxytocin augmentation.

Mechanical method combined with a pharmacological method

There was no evidence of clear benefit for a mechanical method combined with PGE2 compared to PGE2 alone or to oxytocin. When compared to low‐dose misoprostol, a mechanical method combined with PGE2 may reduce the risk of a vaginal delivery not achieved within 24 hours. However, only one study (127 women) reported on this comparison. When a mechanical method is combined with oxytocin, it may reduce the risk of a NICU admission when compared to misoprostol alone. However, regarding other perinatal outcomes for both comparisons, there was no evidence for a difference in serious neonatal morbidity or perinatal death, Apgar scores less than seven at five minutes or fetal distress.

Infection

Risk of infection may theoretically be associated with the insertion of foreign material in the cervix. Most studies did not report on this outcome, resulting in limited data, reported as various outcomes (maternal fever during labour, antibiotic use during labour, chorioamnionitis and endometritis). According to the limited data available, there is no evidence of an increased risk of infectious morbidity with mechanical methods. These data should however be cautiously interpreted as results were imprecise.

Women's view

Data on patient satisfaction or patient preferences are sparse and not all data could be included in the meta‐analyses. When a balloon catheter was compared to vaginal PGE2, more women who were randomised to a balloon would choose the allocated induction method again in a subsequent pregnancy, as compared to women who were randomised to PGE2. However, when a balloon catheter was compared to oral misoprostol, more women would choose misoprostol in a subsequent pregnancy. For both outcomes, only one study was included.

Overall completeness and applicability of evidence

This review was previously one of a series of Cochrane Reviews examining various methods for induction of labour and now serves as a stand‐alone review. Other reviews have examined pharmacological and non‐pharmacological methods including vaginal prostaglandins (Thomas 2014); intracervical prostaglandins (Boulvain 2008); intravenous oxytocin (Alferivic 2009); amniotomy (Bricker 2000); intravenous oxytocin with amniotomy (Howarth 2001); vaginal misoprostol (Hofmeyr 2010); oral misoprostol (Alfirevic 2014), and other methods.

Despite including 112 studies and including data from 104 studies, there were relatively few clear results. Only for the comparison of a balloon versus vaginal prostaglandin E2, including 28 studies involving 6619 women, were there enough data to make a valid judgement on effectiveness and adverse events between these methods.

Most of the outcomes of interest were poorly reported in the included studies, especially serious maternal or perinatal morbidity or death. Also, for some outcomes such as duration from start of induction to vaginal delivery, Apgar score or umbilical cord pH, only continuous data were reported and therefore were not included in this review. Outcomes should therefore be interpreted with caution. Caesarean section on the other hand, was reported in almost every study. Therefore, caesarean section may be the most reliable outcome by which to assess the effectiveness of mechanical methods for cervical ripening and induction of labour.

The external validity of our results can be questioned as the policy of labour induction varies across the different settings in which trials took place. There was a difference seen in maximum ripening time (e.g. the maximum time cervical ripening was awaited, ranging from six hours to 96 hours) and for when induction of labour was declared as failed. As it may take longer to achieve successful cervical ripening when a balloon is used, this could influence the outcome measures of effectiveness used, such as caesarean section. Also, the caesarean rate differs according to the setting in which trials took place, ranging from 9% (Deshmukh 2011) to 70% (Hudon 1999).

Studies ranged in date of publication from 1982 to 2018. While we did not consider the potential influence of date on our results, it is possible that changes in management of labour can mean that for some comparisons, in which relatively older studies were included, may not be generalisable to the current clinical context.

Quality of the evidence

Risk of bias varied throughout the included trials (see Figure 2 and Figure 3). A great proportion of the trial methods were not well reported and were assessed to be at unclear risk of bias in many domains. Three trials were assessed as using inadequate random sequence generation, and in five trials no measures were taken to conceal allocation. In almost all studies, no blinding was done due to the nature of the intervention. However, blinding of the research personnel would have been possible, but was only described in four studies. Two studies reported to have performed a double‐blind study, but did not describe how this was achieved. We rated many trials at unclear risk of attrition bias, mainly because it was not clear if intention‐to‐treat was performed. Although we did attempt to assess reporting bias, lack of trial protocols for most of the older studies, meant this assessment relied on information available in the published trial report.

The outcomes were assessed using the GRADE approach. We determined the evidence to be moderate‐quality, low‐quality or very low‐quality. All evidence was downgraded for lack of blinding. Other reasons for downgrading were predominately for imprecision (uncertain effect estimates, small sample sizes and low event rates) and inconsistencies (heterogeneity). For our three main comparisons (balloon versus vaginal PGE2; balloon versus vaginal misoprostol; balloon versus oral misoprostol), a 'Summary of findings' table was produced (summary of findings Table 1; summary of findings Table 2; summary of findings Table 3).

Although no publication bias was detected for our main outcomes, there is still a possibility of publication bias. Most comparisons had less than 10 studies included and therefore, a funnel plot could not be produced. Also, for 11 trial registrations the anticipated end date was overdue by two years and it was not clear if the trials had started, were ongoing or finished recruiting (Baacke 2006; Behrashi 2013; Cullimore 2009; Dias 2008; EUCTR 2012; Kamilya 2011; Park 2011; Pathiraja 2014; Reif 2012; Yazdani 2011; Zhang 2014). Therefore, a potential risk exists as results from these studies were not published.

We acknowledge that with so many comparisons within the review, there is also a risk of statistical type 1 error, meaning a false‐positive result. The results where there are very few studies included, moderate or substantial heterogeneity, or those where the meta‐analysis result is of borderline statistical significance must therefore be treated with caution.

Potential biases in the review process

We are aware that the possibility of introducing bias was present at every stage of the reviewing process. We attempted to minimise bias in a number of ways; two review authors assessed studies for eligibility, assessed risk of bias and carried out data extraction. Each review author worked independently. We resolved discrepancies through discussion, or if required we consulted a third review author. Nevertheless, the process of assessing risk of bias, for example, is not an exact science and includes many personal judgements. Four review authors, Mieke ten Eikelder, Marta Jozwiak, Kitty Bloemenkamp and Ben Willem Mol are also trial authors for the following included studies: Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; ten Eikelder 2016. Data extraction and risk of bias assessments were conducted by other review authors for these studies (Marieke de Vaan; Kirsten Palmer).

Agreements and disagreements with other studies or reviews

This review is one the most extensive reviews on mechanical methods of labour induction as most reviews on this subject only contain one or two of the comparisons included in this review. We found eight recent systematic reviews covering one or more of our main comparisons, being balloon versus vaginal PGE2, balloon versus vaginal misoprostol or balloon versus oral misoprostol.

Our review was in line with other systematic reviews on induction of labour with a balloon versus vaginal PGE2. Liu 2018 compared a double balloon with a vaginal PGE2 insert and they found no difference in vaginal deliveries achieved within 24 hours or caesarean section rate. They also found a reduction in uterine hyperstimulation and umbilical artery pH < 7.10 when a balloon was used. All of the five studies included in the review of Liu 2018, were also included in our review. Du 2017 compared a double balloon with PGE2 (vaginal as well as cervical) and produced the same results as described in our review and the review of Liu 2018. However, they found no difference in fetal distress for which a caesarean section was indicated. All eight studies were also included in this review. Zhu 2018 compared a Foley catheter with a vaginal PGE2 and included eight studies of which one (Ghanaie 2013) was excluded in our review because oxytocin was administered concurrent to both induction methods. Just as the other reviews, Zhu 2018 found no difference in caesarean section rate. They also looked at the induction to delivery interval on a continuous level and found no difference between both induction methods. Wang 2016 however, found a longer induction to delivery interval when a Foley catheter was used in comparison to PGE2 vaginal insert. The authors did not compare vaginal delivery rates within 24 hours.

Chen 2016 performed a network meta‐analysis in which direct and indirect comparisons between different induction agents, including Foley catheter, vaginal PGE2, vaginal misoprostol and oral misoprostol were made. Studies with high‐dose misoprostol were included in the review of Chen 2016 as opposed to our review and only indirect comparisons could be made between a Foley catheter and oral misoprostol in the review of Chen 2016. The outcomes of interest were vaginal delivery not achieved within 24 hours, uterine hyperstimulation with FHR changes and caesarean section. Not all results were in line with our results. In the network meta‐analysis, a Foley catheter increased the risk of vaginal delivery not achieved within 24 hours compared to vaginal misoprostol, where in our review the outcome was uncertain. When compared to oral misoprostol, no clear difference in vaginal deliveries within 24 hours was seen by Chen 2016 compared to an increased risk in our review. In our review no clear difference was seen in uterine hyperstimulation with FHR changes, but in the network analysis of Chen 2016, a reduced risk was seen when a Foley catheter was used compared to oral misoprostol. For the outcome of caesarean section, the network meta‐analyses of Chen 2016 showed the same results as our review. They found that a Foley catheter may slightly increase the risk of a caesarean section when compared to vaginal or oral misoprostol, with moderate heterogeneity for the comparison with vaginal misoprostol.

Alfirevic 2016 performed a extensive systematic review on induction of labour. The authors included 34 active treatment types/regimens including different dose regimens and routes of administration, and performed a network meta‐analysis in which all different treatments were ranked in relation to each other, including direct as well as indirect comparisons. Ranking was done on absolute risks for all pre specified outcomes. Mechanical induction with a balloon was divided in a single or double balloon. Alfirevic 2016 used other cut‐off points in dividing oral and vaginal tablets in dose regimens. In our review low dose was defined as ≤ 50 mcg every ≥ four hours, opposed to the cut‐of point of ≥ 50 mcg in the review of Alfirevic 2016. Vaginal PGE2 was divided into tablets, gel, slow‐release and normal‐release inserts. For the outcome of a vaginal delivery not achieved within 24 hours, low‐dose vaginal misoprostol scored better, as well as all different regimens of vaginal PGE2 compared to induction with a balloon (single as well as double). For the outcome caesarean section, a single balloon and vaginal PGE2 gel had a similar mean ranking in the mid regions. Noteworthy is that low‐dose titrated oral misoprostol had one of the lowest mean rankings, as compared to oral misoprostol < 50 mcg, which was ranked relatively high. The same high ranking for this outcome was seen for a double balloon. In line with our review, all mechanical methods had a low ranking regarding uterine hyperstimulation with FHR changes. Alfirevic 2016 also looked at neonatal and maternal mortality and severe morbidity, but for these composite outcomes no network meta‐analysis was possible as events were rare and poorly reported in studies. For the outcomes of NICU‐admission as well as five‐minute Apgar score less than seven, there was considerable uncertainty on the probability of the mean ranking as the 95% confidence intervals (CIs) for these rankings were relatively broad.

Ten Eikelder 2016 looked at safety outcomes between induction of labour with a Foley catheter and misoprostol (any route, any dose) and found less uterine hyperstimulation with FHR changes and less fetal distress for which a caesarean section was indicated when a Foley was used. They found that a Foley catheter may slightly increase the caesarean section rate, although conventional statistical significance was not reached and there was moderate heterogeneity for this outcome. Studies with high‐dose misoprostol were not excluded in the review of Ten Eikelder 2016. In subgroup analyses for 25 mcg and 50 mcg vaginal misoprostol, no evidence for a difference in safety outcomes were found.

In our review, there was no evidence for a difference in outcomes related to infection between mechanical induction and other methods for induction of labour. However, the results of outcomes covering infection were still too imprecise to make a valid judgement. McMaster 2015 addressed this question by comparing induction of labour with a balloon versus locally‐applied prostaglandin and included 26 trials. Their results were in line with our results and found no evidence for a difference in chorioamnionitis, endometritis and neonatal infection. When infection outcomes were pooled, little or no difference was seen, suggesting a Foley catheter does not increase the risk of infection compared to locally‐applied prostaglandin.

Figure 1

Study flow diagram.

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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.3 Caesarean section.

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Figure 5

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.6 Oxytocin augmentation.

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Figure 6

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.7 Uterine hyperstimulation without fetal heart rate changes.

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Figure 7

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.10 Instrumental vaginal delivery.

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Figure 8

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.12 Apgar score < 7 at 5 minutes.

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Figure 9

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.13 Neonatal intensive care unit admission.

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Figure 10

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.21 Fetal distress.

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Figure 11

Funnel plot of comparison: 4 Balloon (Foley or ATAD) versus intracervical Prostaglandin E2: all women, outcome: 4.3 Caesarean section.

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Figure 12

Funnel plot of comparison: 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, outcome: 7.3 Caesarean section.

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Analysis 1.1

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 1.2

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 1.3

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 3: Caesarean section

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Analysis 1.4

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 1.5

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 5: Serious maternal morbidity or death

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Analysis 1.6

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 6: Oxytocin augmentation

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Analysis 1.7

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 7: Uterine hyperstimulation without fetal heart rate changes

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Analysis 1.8

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 8: Uterine rupture

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Analysis 1.9

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 9: Epidural analgesia

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Analysis 1.10

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 10: Instrumental vaginal delivery

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Analysis 1.11

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 11: Meconium‐stained liquor

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Analysis 1.12

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 12: Apgar score < 7 at 5 minutes

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Analysis 1.13

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 13: Neonatal intensive care unit admission

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Analysis 1.14

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 14: Perinatal death

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Analysis 1.15

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 15: Postpartum haemorrhage

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Analysis 1.16

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 16: Women not satisfied

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Analysis 1.17

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 17: Maternal fever during labour

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Analysis 1.18

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 18: Antibiotics during labour

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Analysis 1.19

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 19: Chorioamnionitis

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Analysis 1.20

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 20: Endometritis

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Analysis 1.21

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 21: Fetal distress

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Analysis 1.22

Comparison 1: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 22: Umbilical artery pH < 7.10

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Analysis 2.1

Comparison 2: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 2.2

Comparison 2: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 2.3

Comparison 2: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 3: Caesarean section

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Analysis 2.4

Comparison 2: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 2.5

Comparison 2: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 5: Serious maternal morbidity or death

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Analysis 3.1

Comparison 3: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all multiparae, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 3.2

Comparison 3: Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all multiparae, Outcome 2: Caesarean section

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Analysis 4.1

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 4.2

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 4.3

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 3: Caesarean section

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Analysis 4.4

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 4.5

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 5: Cervix unfavourable/unchanged after 24 hours

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Analysis 4.6

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 6: Oxytocin augmentation

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Analysis 4.7

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 7: Uterine hyperstimulation without FHR changes

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Analysis 4.8

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 8: Epidural analgesia

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Analysis 4.9

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 9: Instrumental vaginal delivery

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Analysis 4.10

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 10: Meconium‐stained liquor

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Analysis 4.11

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 11: Apgar score < 7 at 5 minutes

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Analysis 4.12

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 12: Neonatal intensive care unit admission

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Analysis 4.13

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 13: Perinatal death

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Analysis 4.14

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 14: Maternal side effects

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Analysis 4.15

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 15: Postpartum haemorrhage

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Analysis 4.16

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 16: Chorioamnionitis

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Analysis 4.17

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 17: Endometritis

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Analysis 4.18

Comparison 4: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 18: Fetal distress

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Analysis 5.1

Comparison 5: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all primiparae, Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 5.2

Comparison 5: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all primiparae, Outcome 2: Caesarean section

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Analysis 6.1

Comparison 6: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all multiparae, Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 6.2

Comparison 6: Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all multiparae, Outcome 2: Caesarean section

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Analysis 7.1

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 7.2

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 7.3

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 3: Caesarean section

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Analysis 7.4

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 7.5

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 5: Serious maternal morbidity or death

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Analysis 7.6

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 6: Cervix unfavourable/unchanged after 12 hours

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Analysis 7.7

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 7: Oxytocin augmentation

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Analysis 7.8

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 8: Uterine hyperstimulation without FHR changes

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Analysis 7.9

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 9: Uterine rupture

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Analysis 7.10

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 10: Epidural analgesia

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Analysis 7.11

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 11: Instrumental vaginal delivery

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Analysis 7.12

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 12: Meconium‐stained liquor

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Analysis 7.13

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 13: Apgar score < 7 at 5 minutes

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Analysis 7.14

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 14: Neonatal intensive care unit admission

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Analysis 7.15

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 15: Perinatal death

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Analysis 7.16

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 16: Maternal vomiting

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Analysis 7.17

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 17: Postpartum haemorrhage

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Analysis 7.18

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 18: Maternal fever during labour

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Analysis 7.19

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 19: Chorioamnionitis

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Analysis 7.20

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 20: Endometritis

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Analysis 7.21

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 21: Fetal distress

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Analysis 7.22

Comparison 7: Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 22: Umbilical artery pH <7.10

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Analysis 8.1

Comparison 8: Balloon (Foley or ATAD versus low dose vaginal misoprostol: all primiparae, Outcome 1: Caesarean section

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Analysis 9.1

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 1: Vaginal delivery not achieved within 24 hours

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Analysis 9.2

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 9.3

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 3: Caesarean section

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Analysis 9.4

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 4: Serious perinatal morbidity/perinatal death

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Analysis 9.5

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 5: Serious maternal morbidity or death

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Analysis 9.6

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 6: Cervix unfavourable after 24 hours

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Analysis 9.7

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 7: Oxytocin augmentation

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Analysis 9.8

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 8: Uterine hyperstimulation without FHR changes

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Analysis 9.9

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 9: Uterine rupture

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Analysis 9.10

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 10: Epidural

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Analysis 9.11

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 11: Instrumental vaginal delivery

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Analysis 9.12

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 12: Meconium‐stained liquor

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Analysis 9.13

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 13: Apgar score < 7 after 5 minutes

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Analysis 9.14

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 14: Neonatal intensive care unit admission

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Analysis 9.15

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 15: Neonatal encephalopathy

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Analysis 9.16

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 16: Perinatal death

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Analysis 9.17

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 17: Maternal side effects (all)

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Analysis 9.18

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 18: Maternal vomiting

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Analysis 9.19

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 19: Maternal diarrhoea

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Analysis 9.20

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 20: Postpartum haemorrhage

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Analysis 9.21

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 21: Maternal death

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Analysis 9.22

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 22: Women not satisfied

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Analysis 9.23

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 23: Maternal fever during labour

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Analysis 9.24

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 24: Antibiotics during labour

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Analysis 9.25

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 25: Endometritis

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Analysis 9.26

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 26: Fetal distress

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Analysis 9.27

Comparison 9: Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 27: Umbilical artery pH < 7.10

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Analysis 10.1

Comparison 10: Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 10.2

Comparison 10: Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 10.3

Comparison 10: Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 3: Caesarean section

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Analysis 10.4

Comparison 10: Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 10.5

Comparison 10: Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 5: Serious maternal morbidity or death

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Analysis 11.1

Comparison 11: Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 11.2

Comparison 11: Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 11.3

Comparison 11: Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 3: Caesarean section

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Analysis 11.4

Comparison 11: Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 11.5

Comparison 11: Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 5: Serious maternal morbidity or death

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Analysis 12.1

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 12.2

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 2: Caesarean section

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Analysis 12.3

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 3: Serious neonatal morbidity/perinatal death

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Analysis 12.4

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 4: Serious maternal morbidity or death

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Analysis 12.5

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 5: Cervix unfavourable after 24 hours

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Analysis 12.6

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 6: Uterine hyperstimulation without FHR changes

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Analysis 12.7

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 7: Uterine rupture

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Analysis 12.8

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 8: Instrumental vaginal delivery

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Analysis 12.9

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 9: Meconium‐stained liquor

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Analysis 12.10

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 10: Apgar score < 7 at 5 minutes

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Analysis 12.11

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 11: Neonatal intensive care unit admission

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Analysis 12.12

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 12: Perinatal death

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Analysis 12.13

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 13: Hemorrhagia postpartum

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Analysis 12.14

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 14: Maternal fever during labour

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Analysis 12.15

Comparison 12: Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 15: Fetal distress

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Analysis 13.1

Comparison 13: Balloon (Foley or ATAD) versus oxytocin: previous caesarean section, Outcome 1: Caesarean section

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Analysis 13.2

Comparison 13: Balloon (Foley or ATAD) versus oxytocin: previous caesarean section, Outcome 2: Serious neonatal morbidity/perinatal death

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Analysis 13.3

Comparison 13: Balloon (Foley or ATAD) versus oxytocin: previous caesarean section, Outcome 3: Serious maternal morbidity or death

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Analysis 14.1

Comparison 14: Balloon (Foley or ATAD) versus oxytocin: all primiparae, Outcome 1: Caesarean section

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Analysis 14.2

Comparison 14: Balloon (Foley or ATAD) versus oxytocin: all primiparae, Outcome 2: Serious maternal morbidity or death

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Analysis 15.1

Comparison 15: Balloon (foley or ATAD) versus amniotomy: all women, Outcome 1: Caesarean section

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Analysis 16.1

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 16.2

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 16.3

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 3: Caesarean section

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Analysis 16.4

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 4: Serious maternal morbidity or death

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Analysis 16.5

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 5: Oxytcocin augmentation

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Analysis 16.6

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 6: Uterine hyperstimulation without FHR changes

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Analysis 16.7

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 7: Uterine rupture

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Analysis 16.8

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 8: Epidural analgesia

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Analysis 16.9

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 9: Instrumental vaginal delivery

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Analysis 16.10

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 10: Meconium‐stained liquor

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Analysis 16.11

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 11: Apgar score < 7 at 5 minutes

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Analysis 16.12

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 12: Neonatal intensive care unit admission

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Analysis 16.13

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 13: Other maternal side‐effects: pain after insertion

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Analysis 16.14

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 14: Postpartum haemorrhage

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Analysis 16.15

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 15: Maternal fever during labour

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Analysis 16.16

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 16: Antibiotics during labour

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Analysis 16.17

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 17: Chorioamnionitis

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Analysis 16.18

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 18: Endometritis

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Analysis 16.19

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 19: Fetal distress

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Analysis 16.20

Comparison 16: Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 20: Umbilical artery pH < 7.10

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Analysis 17.1

Comparison 17: Single balloon (Foley) versus double balloon (ATAD): all primiparae, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 17.2

Comparison 17: Single balloon (Foley) versus double balloon (ATAD): all primiparae, Outcome 2: Caesarean section

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Analysis 18.1

Comparison 18: Single balloon (Foley) versus double balloon (ATAD): all multiparae, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 18.2

Comparison 18: Single balloon (Foley) versus double balloon (ATAD): all multiparae, Outcome 2: Caesarean section

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Analysis 19.1

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 19.2

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 2: Caesarean section

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Analysis 19.3

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 3: Serious perinatal morbidity/perinatal death

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Analysis 19.4

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 4: Serious maternal morbidity or death

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Analysis 19.5

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 5: Uterine hyperstimulation without fetal heart rate changes

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Analysis 19.6

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 6: Epidural analgesia

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Analysis 19.7

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 7: Instrumental vaginal delivery

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Analysis 19.8

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 8: Meconium‐stained liquor

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Analysis 19.9

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 9: Apgar score < 7 at 5 minutes

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Analysis 19.10

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 10: Perinatal death

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Analysis 19.11

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 11: Maternal side effects: all

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Analysis 19.12

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 12: Maternal nausea

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Analysis 19.13

Comparison 19: Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 13: Fetal distress

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Analysis 20.1

Comparison 20: Laminaria tent versus vaginal prostaglandin E2: all primiparae, Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 20.2

Comparison 20: Laminaria tent versus vaginal prostaglandin E2: all primiparae, Outcome 2: Caesarean section

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Analysis 21.1

Comparison 21: Laminaria tent versus vaginal prostaglandin E2: all multiparae, Outcome 1: Caesarean section

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Analysis 22.1

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 22.2

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 2: Caesarean section

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Analysis 22.3

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 3: Serious neonatal morbidity/perinatal death

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Analysis 22.4

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 4: Serious maternal morbidity or death

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Analysis 22.5

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 5: Cervix unfavourable/unchanged after 12‐24 hours

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Analysis 22.6

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 6: Oxytocin augmentation

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Analysis 22.7

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 7: Uterine hyperstimulation without FHR changes

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Analysis 22.8

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 8: Uterine rupture

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Analysis 22.9

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 9: Instrumental vaginal delivery

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Analysis 22.10

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 10: Apgar score < 7 at 5 minutes

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Analysis 22.11

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 11: Neonatal intensive care unit admission

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Analysis 22.12

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 12: Perinatal death

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Analysis 22.13

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 13: Maternal side effects

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Analysis 22.14

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 14: Postpartum haemorrhage

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Analysis 22.15

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 15: Chorioamnionitis

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Analysis 22.16

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 16: Endometritis

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Analysis 22.17

Comparison 22: Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 17: Fetal distress

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Analysis 23.1

Comparison 23: Laminaria tent versus intracervical prostaglandin E2: all primiparae, Outcome 1: Caesarean section

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Analysis 24.1

Comparison 24: Laminaria tent versus intracervical: prostaglandin E2 all multiparae, Outcome 1: Caesarean section

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Analysis 25.1

Comparison 25: Laminaria tent versus oxytocin: all women, Outcome 1: Caesarean section

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Analysis 25.2

Comparison 25: Laminaria tent versus oxytocin: all women, Outcome 2: Fetal distress

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Analysis 26.1

Comparison 26: Laminaria tent versus amniotomy: all women, Outcome 1: Caesarean section

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Analysis 27.1

Comparison 27: Laminaria tent versus other hygroscopic dilator: all women, Outcome 1: Caesarean section

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Analysis 28.1

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 28.2

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 28.3

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 3: Caesarean section

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Analysis 28.4

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 4: Oxytocin augmentation

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Analysis 28.5

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 5: Uterine hyperstimulation without fetal heart rate changes

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Analysis 28.6

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 6: Epidural analgesia

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Analysis 28.7

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 7: Instrumental vaginal delivery

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Analysis 28.8

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 8: Meconium‐stained liquor

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Analysis 28.9

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 9: Apgar score < 7 at 5 minutes

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Analysis 28.10

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 10: Neonatal intensive care unit admission

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Analysis 28.11

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 11: Woman not satisfied

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Analysis 28.12

Comparison 28: EASI versus vaginal prostaglandin E2: all women, Outcome 12: Fetal distress

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Analysis 29.1

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 1: Caesarean section

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Analysis 29.2

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 2: Cervix unfavourable/unchanged after 12‐24 hours

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Analysis 29.3

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 3: Oxytocin augmentation

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Analysis 29.4

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 4: Instrumental vaginal delivery

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Analysis 29.5

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 5: Apgar score < 7 at 5 minutes

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Analysis 29.6

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 6: Endometritis

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Analysis 29.7

Comparison 29: EASI versus intracervical prostaglandin E2: all women, Outcome 7: Fetal distress

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Analysis 30.1

Comparison 30: EASI versus intracervical prostaglandin E2: all primiparae, Outcome 1: Caesarean section

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Analysis 31.1

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 31.2

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 31.3

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 3: Caesarean section

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Analysis 31.4

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 4: Cervix unfavourable/unchanged after 24 hours

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Analysis 31.5

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 5: Oxytocin augmentation

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Analysis 31.6

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 6: Uterine hyperstimulation without FHR changes

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Analysis 31.7

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 7: Epidural analgesia

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Analysis 31.8

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 8: Instrumental vaginal delivery

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Analysis 31.9

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 9: Meconium‐stained liquor

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Analysis 31.10

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 10: Neonatal intensive care unit admission

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Analysis 31.11

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 11: Postpartum haemorrhage

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Analysis 31.12

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 12: Chorioamnionitis

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Analysis 31.13

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 13: Endometritis

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Analysis 31.14

Comparison 31: Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 14: Fetal distress

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Analysis 32.1

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 32.2

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 2: Caesarean section

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Analysis 32.3

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 3: Serious neonatal morbidity/perinatal death

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Analysis 32.4

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 4: Cervix unfavourable/unchanged after 12‐24 hours

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Analysis 32.5

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 5: Oxytocin augmentation

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Analysis 32.6

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 6: Uterine hyperstimulation without FHR changes

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Analysis 32.7

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 7: Instrumental vaginal delivery

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Analysis 32.8

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 8: Meconium‐stained liquor

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Analysis 32.9

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 9: Apgar score < 7 at 5 minutes

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Analysis 32.10

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 10: Neonatal intensive care unit admission

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Analysis 32.11

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 11: Perinatal death

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Analysis 32.12

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 12: Chorioamnionitis

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Analysis 32.13

Comparison 32: Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 13: Endometritis

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Analysis 33.1

Comparison 33: Any mechanical method and prostaglandin E2 versus oxytocin alone: all women, Outcome 1: Caesarean section

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Analysis 33.2

Comparison 33: Any mechanical method and prostaglandin E2 versus oxytocin alone: all women, Outcome 2: Instrumental vaginal delivery

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Analysis 33.3

Comparison 33: Any mechanical method and prostaglandin E2 versus oxytocin alone: all women, Outcome 3: Endometritis

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Analysis 34.1

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 34.2

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 34.3

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 3: Caesarean section

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Analysis 34.4

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 34.5

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 5: Serious maternal morbidity or death

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Analysis 34.6

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 6: Oxytocin augmentation

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Analysis 34.7

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 7: Uterine hyperstimulation without fetal heart rate changes

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Analysis 34.8

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 8: Uterine rupture

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Analysis 34.9

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 9: Instrumental vaginal delivery

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Analysis 34.10

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 10: Meconium‐stained liquor

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Analysis 34.11

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 11: Apgar score < 7 at 5 minutes

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Analysis 34.12

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 12: Neonatal intensive care unit admission

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Analysis 34.13

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 13: Perinatal death

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Analysis 34.14

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 14: Maternal side effects

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Analysis 34.15

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 15: Maternal nausea

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Analysis 34.16

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 16: Maternal diarrhoea

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Analysis 34.17

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 17: Postpartum haemorrhage

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Analysis 34.18

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 18: Serious maternal complications

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Analysis 34.19

Comparison 34: Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 19: Maternal fever during labour

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Analysis 35.1

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 35.2

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 35.3

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 3: Caesarean section

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Analysis 35.4

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 35.5

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 5: Serious maternal morbidity or death

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Analysis 35.6

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 6: Cervix unfavourable/unchanged after 12 hours

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Analysis 35.7

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 7: Oxytocin augmentation

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Analysis 35.8

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 8: Uterine hyperstimulation without FHR changes

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Analysis 35.9

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 9: Uterine rupture

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Analysis 35.10

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 10: Epidural analgesia

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Analysis 35.11

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 11: Instrumental vaginal delivery

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Analysis 35.12

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 12: Meconium‐stained liquor

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Analysis 35.13

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 13: Apgar score < 7 at 5 minutes

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Analysis 35.14

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 14: Neonatal intensive care unit admission

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Analysis 35.15

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 15: Perinatal death

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Analysis 35.16

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 16: Maternal side effects

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Analysis 35.17

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 17: Maternal nausea

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Analysis 35.18

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 18: Maternal diarrhoea

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Analysis 35.19

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 19: Postpartum haemorrhage

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Analysis 35.20

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 20: Serious maternal complications

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Analysis 35.21

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 21: Chorioamnionitis

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Analysis 35.22

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 22: Endometrits

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Analysis 35.23

Comparison 35: Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 23: Fetal distress

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Analysis 36.1

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 1: Uterine hyperstimulation with FHR changes

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Analysis 36.2

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 2: Caesarean section

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Analysis 36.3

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 3: Serious maternal morbidity or death

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Analysis 36.4

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 4: Oxytocin augmentation

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Analysis 36.5

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 5: Uterine hyperstimulation without FHR changes

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Analysis 36.6

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 6: Instrumental vaginal delivery

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Analysis 36.7

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 7: Meconium‐stained liquor

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Analysis 36.8

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 8: Apgar score < 7 at 5 minutes

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Analysis 36.9

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 9: Neonatal intensive care unit admission

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Analysis 36.10

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 10: Postpartum haemorrhage

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Analysis 36.11

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 11: Endometritis

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Analysis 36.12

Comparison 36: Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 12: Fetal distress

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Analysis 37.1

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 37.2

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 2: Uterine hyperstimulation with FHR changes

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Analysis 37.3

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 3: Caesarean section

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Analysis 37.4

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 4: Serious neonatal morbidity/perinatal death

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Analysis 37.5

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 5: Oxytocin augmentation

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Analysis 37.6

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 6: Uterine hyperstimulation without FHR changes

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Analysis 37.7

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 7: Epidural analgesia

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Analysis 37.8

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 8: Meconium‐stained liquor

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Analysis 37.9

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 9: Apgar score < 7 at 5 minutes

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Analysis 37.10

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 10: Neonatal intensive care unit admission

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Analysis 37.11

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 11: Perinatal death

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Analysis 37.12

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 12: Women not satisfied

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Analysis 37.13

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 13: Maternal fever

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Analysis 37.14

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 14: Chorioamnionitis

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Analysis 37.15

Comparison 37: Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 15: Fetal distress

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Analysis 38.1

Comparison 38: Any mechanical method and oxytocin versus low dose misoprostol alone: all multiparae, Outcome 1: Caesarean section

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Analysis 39.1

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 1: Vaginal delivery not achieved in 24 hours

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Analysis 39.2

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 2: Caesarean section

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Analysis 39.3

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 3: Serious neonatal morbidity/perinatal death

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Analysis 39.4

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 4: Serious maternal morbidity or death

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Analysis 39.5

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 5: Uterine hyperstimulation without FHR changes

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Analysis 39.6

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 6: Uterine rupture

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Analysis 39.7

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 7: Epidural analgesia

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Analysis 39.8

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 8: Instrumental vaginal delivery

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Analysis 39.9

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 9: Meconium‐stained liquor

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Analysis 39.10

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 10: Neonatal intensive care unit admission

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Analysis 39.11

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 11: Postpartum haemorrhage

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Analysis 39.12

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 12: Serious maternal complications

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Analysis 39.13

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 13: Antibiotics during labour

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Analysis 39.14

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 14: Chorionamnionitis

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Analysis 39.15

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 15: Endometritis

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Analysis 39.16

Comparison 39: Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 16: Fetal distress

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Summary of findings 1. Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus
Patient or population: third trimester labour induction in women with a viable fetus Setting: Australia, China, Denmark, Iran, Jordan, India, Italy, Israel, Nigeria, Pakistan, Singapore, Sweden, the Netherlands, USA, UK Intervention: balloon (Foley or ATAD) Comparison: vaginal prostaglandin E2
Outcomes	Risk with vaginal prostaglandin E2	Risk with balloon (Foley or ATAD)	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Vaginal delivery not achieved in 24 hours	Study population		RR 1.01 (0.82 to 1.26)	1685 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Vaginal delivery not achieved in 24 hours	528 per 1000	533 per 1000 (433 to 665)	RR 1.01 (0.82 to 1.26)	1685 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Uterine hyperstimulation with FHR changes	Study population		RR 0.35 (0.18 to 0.67)	1966 (6 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Uterine hyperstimulation with FHR changes	31 per 1000	11 per 1000 (6 to 21)	RR 0.35 (0.18 to 0.67)	1966 (6 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Caesarean section	Study population		RR 1.00 (0.92 to 1.09)	6619 (28 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Caesarean section	238 per 1000	238 per 1000 (219 to 260)	RR 1.00 (0.92 to 1.09)	6619 (28 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Serious neonatal morbidity or perinatal death	Study population		RR 0.48 (0.25 to 0.93)	2757 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Serious neonatal morbidity or perinatal death	20 per 1000	9 per 1000 (5 to 18)	RR 0.48 (0.25 to 0.93)	2757 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Serious maternal morbidity or death	Study population		RR 0.20 (0.01 to 4.12)	1481 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 3}
Serious maternal morbidity or death	3 per 1000	1 per 1000 (0 to 11)	RR 0.20 (0.01 to 4.12)	1481 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 3}
Apgar score < 7 at 5 minutes	Study population		RR 0.74 (0.49 to 1.14)	4271 (14 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
Apgar score < 7 at 5 minutes	22 per 1000	16 per 1000 (11 to 25)	RR 0.74 (0.49 to 1.14)	4271 (14 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
Neonatal intensive care unit admission	Study population		RR 0.82 (0.65 to 1.04)	3647 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
Neonatal intensive care unit admission	74 per 1000	60 per 1000 (48 to 77)	RR 0.82 (0.65 to 1.04)	3647 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 4}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event) ²We downgraded (1) level for serious inconsistency due to evidence of statistical heterogeneity (I² = >30%) ³We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events ⁴We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect

Summary of findings 1. Balloon (Foley or ATAD) compared to vaginal prostaglandin E2 for third trimester labour induction in women with a viable fetus

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Summary of findings 2. Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus
Patient or population: third trimester induction of labour in women with a viable fetus Setting: Brazil, Egypt, India, Iran, Nigeria, the Netherlands, Sweden Intervention: balloon (Foley or ATAD) Comparison: low‐dose vaginal misoprostol
Outcomes	Risk with low‐dose vaginal misoprostol	Risk with balloon (Foley or ATAD)	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Vaginal delivery not achieved in 24 hours	Study population		RR 1.09 (0.85 to 1.39)	340 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Vaginal delivery not achieved in 24 hours	412 per 1000	449 per 1000 (350 to 573)	RR 1.09 (0.85 to 1.39)	340 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Uterine hyperstimulation with FHR changes	Study population		RR 0.39 (0.18 to 0.85)	1322 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Uterine hyperstimulation with FHR changes	33 per 1000	13 per 1000 (6 to 28)	RR 0.39 (0.18 to 0.85)	1322 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Caesarean section	Study population		RR 1.28 (1.02 to 1.60)	1756 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 3}
Caesarean section	243 per 1000	311 per 1000 (247 to 388)	RR 1.28 (1.02 to 1.60)	1756 (12 RCTs)	⊕⊕⊝⊝ LOW ^{1 3}
Serious neonatal morbidity or perinatal death	Study population		RR 0.58 (0.12 to 2.66)	381 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 4}
Serious neonatal morbidity or perinatal death	21 per 1000	12 per 1000 (2 to 55)	RR 0.58 (0.12 to 2.66)	381 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 4}
Serious maternal morbidity or death	Study population		not estimable	464 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}	no events occurred in included studies
Serious maternal morbidity or death	0 per 1000	0 per 1000 (0 to 0)	not estimable	464 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}	no events occurred in included studies
Apgar score < 7 at 5 minutes	Study population		RR 1.00 (0.50 to 1.97)	941 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Apgar score < 7 at 5 minutes	30 per 1000	30 per 1000 (15 to 59)	RR 1.00 (0.50 to 1.97)	941 (7 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Neonatal intensive care unit admission	Study population		RR 1.00 (0.61 to 1.63)	1302 (9 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 6}
Neonatal intensive care unit admission	47 per 1000	47 per 1000 (29 to 77)	RR 1.00 (0.61 to 1.63)	1302 (9 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 6}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event) ²We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect ³We downgraded (1) level for serious inconsistency due to evidence of statistical heterogeneity (I² = >30%) ⁴We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events ⁵ We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and no events reported in included studies ⁶ Although there was some evidence suggesting small‐study effect we did not downgrade for publication bias because individual studies did not reach statistical significance and there was low heterogeneity across all studies for this outcome. Also, no difference was found between fixed‐effect or random‐effect analyses

Summary of findings 2. Balloon (Foley or ATAD) compared to low‐dose vaginal misoprostol for third trimester induction of labour in women with a viable fetus

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Summary of findings 3. Balloon (Foley or ATAD) compared to low‐dose oral misoprostol for third trimester induction of labour in women with a viable fetus

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Balloon (Foley or ATAD) compared to low‐dose oral misoprostol for third trimester induction of labour in women with a viable fetus
Patient or population: third trimester induction of labour in women with a viable fetus Setting: Finland, India, Pakistan, Sri Lanka, the Netherlands Intervention: balloon (Foley or ATAD) Comparison: low‐dose oral misoprostol
Outcomes	Risk with low‐dose oral misoprostol	Risk with balloon (Foley or ATAD)	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Vaginal delivery not achieved within 24 hours	Study population		RR 1.28 (1.13 to 1.46)	782 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Vaginal delivery not achieved within 24 hours	476 per 1000	609 per 1000 (538 to 695)	RR 1.28 (1.13 to 1.46)	782 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Uterine hyperstimulation with FHR changes	Study population		RR 0.81 (0.48 to 1.38)	2033 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Uterine hyperstimulation with FHR changes	29 per 1000	24 per 1000 (14 to 40)	RR 0.81 (0.48 to 1.38)	2033 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Caesarean section	Study population		RR 1.17 (1.04 to 1.32)	3178 (7 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 3}
Caesarean section	222 per 1000	259 per 1000 (230 to 293)	RR 1.17 (1.04 to 1.32)	3178 (7 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 3}
Serious neonatal morbidity or perinatal death	Study population		RR 1.11 (0.60 to 2.06)	2627 (3 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Serious neonatal morbidity or perinatal death	14 per 1000	16 per 1000 (9 to 30)	RR 1.11 (0.60 to 2.06)	2627 (3 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Serious maternal morbidity or death	Study population		RR 0.50 (0.05 to 5.52)	2627 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}
Serious maternal morbidity or death	2 per 1000	1 per 1000 (0 to 8)	RR 0.50 (0.05 to 5.52)	2627 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5}
Apgar score < 7 after 5 minutes	Study population		RR 0.71 (0.38 to 1.32)	2693 (4 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Apgar score < 7 after 5 minutes	18 per 1000	13 per 1000 (6 to 28)	RR 0.71 (0.38 to 1.32)	2693 (4 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Neonatal intensive care unit admission	Study population		RR 0.82 (0.58 to 1.17)	2873 (5 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
Neonatal intensive care unit admission	46 per 1000	37 per 1000 (26 to 53)	RR 0.82 (0.58 to 1.17)	2873 (5 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 4}
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹We downgraded (1) level for serious limitation in study design due to lack of blinding (although not feasible due to nature of event) ²We downgraded (1) level for serious imprecision due to wide CI crossing the line of no effect ³ Trial of Mundle 2017 did not meet the pre‐specified population as pregnancies with a non viable fetus were included. Sensitivity analyses did not alter the estimated effect size. Therefore we did not downgrade ⁴ Trial of Mundle 2017 did not meet the pre‐specified population as pregnancies with a non viable fetus were included. Sensitivity analysis did not change the direction of the effect size and numbers of events were not higher compared to other trials. Therefore we did not downgrade. ⁵ We downgraded (2) levels for very serious imprecision due to wide CI crossing the line of no effect and small number of events

Summary of findings 3. Balloon (Foley or ATAD) compared to low‐dose oral misoprostol for third trimester induction of labour in women with a viable fetus

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Comparison 1. Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Vaginal delivery not achieved in 24 hours Show forest plot	7	1685	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.82, 1.26]

1.2 Uterine hyperstimulation with FHR changes Show forest plot	6	1966	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.18, 0.67]

1.3 Caesarean section Show forest plot	28	6619	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.92, 1.09]

1.4 Serious neonatal morbidity/perinatal death Show forest plot	8	2757	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.25, 0.93]

1.5 Serious maternal morbidity or death Show forest plot	4	1481	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.12]

1.6 Oxytocin augmentation Show forest plot	16	4828	Risk Ratio (M‐H, Random, 95% CI)	1.54 [1.35, 1.76]

1.7 Uterine hyperstimulation without fetal heart rate changes Show forest plot	15	2444	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.11, 0.66]

1.8 Uterine rupture Show forest plot	2	1045	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.12]

1.9 Epidural analgesia Show forest plot	8	2828	Risk Ratio (M‐H, Random, 95% CI)	1.14 [1.00, 1.29]

1.10 Instrumental vaginal delivery Show forest plot	16	4514	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.79, 1.09]

1.11 Meconium‐stained liquor Show forest plot	4	964	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.67, 1.19]

1.12 Apgar score < 7 at 5 minutes Show forest plot	14	4271	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.49, 1.14]

1.13 Neonatal intensive care unit admission Show forest plot	12	3647	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.65, 1.04]

1.14 Perinatal death Show forest plot	5	1036	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.01, 4.27]

1.15 Postpartum haemorrhage Show forest plot	8	2215	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.63, 1.06]

1.16 Women not satisfied Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.39, 0.97]

1.17 Maternal fever during labour Show forest plot	7	2362	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.65, 1.17]

1.18 Antibiotics during labour Show forest plot	1	330	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.89, 2.29]

1.19 Chorioamnionitis Show forest plot	1	376	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.32, 1.49]

1.20 Endometritis Show forest plot	2	706	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.19, 1.27]

1.21 Fetal distress Show forest plot	20	4753	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.60, 0.83]

1.22 Umbilical artery pH < 7.10 Show forest plot	8	2675	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.44, 0.94]

Comparison 1. Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women

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Comparison 2. Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	330	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.83, 1.23]

2.2 Uterine hyperstimulation with FHR changes Show forest plot	1	330	Risk Ratio (M‐H, Fixed, 95% CI)	0.05 [0.00, 0.85]

2.3 Caesarean section Show forest plot	5	828	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.59, 1.33]

2.4 Serious neonatal morbidity/perinatal death Show forest plot	1	330	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.01, 4.24]

2.5 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 2. Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae

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Comparison 3. Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	147	Risk Ratio (M‐H, Fixed, 95% CI)	4.38 [1.74, 10.98]

3.2 Caesarean section Show forest plot	2	180	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [0.65, 2.63]

Comparison 3. Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all multiparae

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Comparison 4. Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Vaginal delivery not achieved in 24 hours Show forest plot	2	200	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.35, 2.91]

4.2 Uterine hyperstimulation with FHR changes Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.02, 8.90]

4.3 Caesarean section Show forest plot	9	1309	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.81, 1.15]

4.4 Serious neonatal morbidity/perinatal death Show forest plot	2	500	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.29, 2.05]

4.5 Cervix unfavourable/unchanged after 24 hours Show forest plot	2	219	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.70, 1.34]

4.6 Oxytocin augmentation Show forest plot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.93, 1.26]

4.7 Uterine hyperstimulation without FHR changes Show forest plot	5	654	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.09, 10.38]

4.8 Epidural analgesia Show forest plot	1	149	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.81, 1.02]

4.9 Instrumental vaginal delivery Show forest plot	3	337	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.68, 2.05]

4.10 Meconium‐stained liquor Show forest plot	1	118	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.42, 3.26]

4.11 Apgar score < 7 at 5 minutes Show forest plot	2	475	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.41, 1.53]

4.12 Neonatal intensive care unit admission Show forest plot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.60, 1.31]

4.13 Perinatal death Show forest plot	2	500	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.29, 2.05]

4.14 Maternal side effects Show forest plot	2	211	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.02, 1.24]

4.15 Postpartum haemorrhage Show forest plot	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.06]

4.16 Chorioamnionitis Show forest plot	1	118	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.21, 4.75]

4.17 Endometritis Show forest plot	1	118	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.06, 15.61]

4.18 Fetal distress Show forest plot	6	1023	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.42, 0.89]

Comparison 4. Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women

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Comparison 5. Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Uterine hyperstimulation with FHR changes Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

5.2 Caesarean section Show forest plot	3	245	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.86, 1.95]

Comparison 5. Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all primiparae

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Comparison 6. Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Uterine hyperstimulation with FHR changes Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.01, 7.02]

6.2 Caesarean section Show forest plot	3	136	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.16, 2.78]

Comparison 6. Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all multiparae

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Comparison 7. Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Vaginal delivery not achieved in 24 hours Show forest plot	2	340	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.85, 1.39]

7.2 Uterine hyperstimulation with FHR changes Show forest plot	8	1322	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.18, 0.85]

7.3 Caesarean section Show forest plot	12	1756	Risk Ratio (M‐H, Random, 95% CI)	1.28 [1.02, 1.60]

7.4 Serious neonatal morbidity/perinatal death Show forest plot	3	381	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.12, 2.66]

7.5 Serious maternal morbidity or death Show forest plot	4	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

7.6 Cervix unfavourable/unchanged after 12 hours Show forest plot	2	200	Risk Ratio (M‐H, Random, 95% CI)	2.66 [0.60, 11.89]

7.7 Oxytocin augmentation Show forest plot	9	911	Risk Ratio (M‐H, Random, 95% CI)	1.62 [1.38, 1.90]

7.8 Uterine hyperstimulation without FHR changes Show forest plot	9	1139	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.14, 0.44]

7.9 Uterine rupture Show forest plot	3	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

7.10 Epidural analgesia Show forest plot	2	517	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [1.06, 1.41]

7.11 Instrumental vaginal delivery Show forest plot	4	721	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.50, 1.05]

7.12 Meconium‐stained liquor Show forest plot	7	1268	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.48, 0.87]

7.13 Apgar score < 7 at 5 minutes Show forest plot	7	941	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.50, 1.97]

7.14 Neonatal intensive care unit admission Show forest plot	9	1302	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.61, 1.63]

7.15 Perinatal death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

7.16 Maternal vomiting Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

7.17 Postpartum haemorrhage Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.24, 5.44]

7.18 Maternal fever during labour Show forest plot	3	617	Risk Ratio (M‐H, Random, 95% CI)	1.84 [0.22, 15.62]

7.19 Chorioamnionitis Show forest plot	2	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.31, 4.88]

7.20 Endometritis Show forest plot	1	240	Risk Ratio (M‐H, Fixed, 95% CI)	2.95 [0.12, 71.72]

7.21 Fetal distress Show forest plot	7	1127	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.67, 1.05]

7.22 Umbilical artery pH <7.10 Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.35, 3.74]

Comparison 7. Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women

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Comparison 8. Balloon (Foley or ATAD versus low dose vaginal misoprostol: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
8.1 Caesarean section Show forest plot	1	255	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.59, 1.13]

Comparison 8. Balloon (Foley or ATAD versus low dose vaginal misoprostol: all primiparae

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Comparison 9. Balloon (Foley or ATAD) versus low dose oral misoprostol: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
9.1 Vaginal delivery not achieved within 24 hours Show forest plot	2	782	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [1.13, 1.46]

9.2 Uterine hyperstimulation with FHR changes Show forest plot	2	2033	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.48, 1.38]

9.3 Caesarean section Show forest plot	7	3178	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [1.04, 1.32]

9.4 Serious perinatal morbidity/perinatal death Show forest plot	3	2627	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.60, 2.06]

9.5 Serious maternal morbidity or death Show forest plot	3	2627	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.05, 5.52]

9.6 Cervix unfavourable after 24 hours Show forest plot	4	994	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.61, 1.56]

9.7 Oxytocin augmentation Show forest plot	5	2847	Risk Ratio (M‐H, Random, 95% CI)	1.28 [1.09, 1.49]

9.8 Uterine hyperstimulation without FHR changes Show forest plot	5	2838	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.12, 2.07]

9.9 Uterine rupture Show forest plot	3	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

9.10 Epidural Show forest plot	3	2635	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.96, 1.22]

9.11 Instrumental vaginal delivery Show forest plot	3	2627	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.55, 0.92]

9.12 Meconium‐stained liquor Show forest plot	3	2627	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.44, 1.35]

9.13 Apgar score < 7 after 5 minutes Show forest plot	4	2693	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.38, 1.32]

9.14 Neonatal intensive care unit admission Show forest plot	5	2873	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.58, 1.17]

9.15 Neonatal encephalopathy Show forest plot	1	600	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.32, 2.03]

9.16 Perinatal death Show forest plot	3	2627	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.49, 3.30]

9.17 Maternal side effects (all) Show forest plot	2	662	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.33, 1.13]

9.18 Maternal vomiting Show forest plot	2	662	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.37, 1.46]

9.19 Maternal diarrhoea Show forest plot	1	602	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.06, 1.37]

9.20 Postpartum haemorrhage Show forest plot	5	2966	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.79, 1.34]

9.21 Maternal death Show forest plot	3	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

9.22 Women not satisfied Show forest plot	1	602	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [1.15, 2.50]

9.23 Maternal fever during labour Show forest plot	2	2033	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.78, 1.24]

9.24 Antibiotics during labour Show forest plot	2	2033	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.75, 2.00]

9.25 Endometritis Show forest plot	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.05, 6.03]

9.26 Fetal distress Show forest plot	5	2966	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.61, 1.09]

9.27 Umbilical artery pH < 7.10 Show forest plot	2	1535	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.53, 1.12]

Comparison 9. Balloon (Foley or ATAD) versus low dose oral misoprostol: all women

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Comparison 10. Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
10.1 Vaginal delivery not achieved in 24 hours Show forest plot	2	573	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [1.04, 1.37]

10.2 Uterine hyperstimulation with FHR changes Show forest plot	1	1206	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.45, 1.46]

10.3 Caesarean section Show forest plot	3	1778	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.06, 1.38]

10.4 Serious neonatal morbidity/perinatal death Show forest plot	2	1296	Risk Ratio (M‐H, Fixed, 95% CI)	4.49 [0.77, 26.14]

10.5 Serious maternal morbidity or death Show forest plot	2	1296	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.05, 5.63]

Comparison 10. Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae

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Comparison 11. Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
11.1 Vaginal delivery not achieved in 24 hours Show forest plot	2	209	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [1.17, 2.06]

11.2 Uterine hyperstimulation with FHR changes Show forest plot	1	639	Risk Ratio (M‐H, Fixed, 95% CI)	1.45 [0.24, 8.61]

11.3 Caesarean section Show forest plot	3	848	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.79, 1.87]

11.4 Serious neonatal morbidity/perinatal death Show forest plot	2	729	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.14, 6.86]

11.5 Serious maternal morbidity or death Show forest plot	2	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 11. Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae

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Comparison 12. Balloon (Foley or ATAD) versus oxytocin: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
12.1 Uterine hyperstimulation with FHR changes Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.11]

12.2 Caesarean section Show forest plot	8	781	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.56, 0.83]

12.3 Serious neonatal morbidity/perinatal death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

12.4 Serious maternal morbidity or death Show forest plot	2	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

12.5 Cervix unfavourable after 24 hours Show forest plot	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.20, 1.54]

12.6 Uterine hyperstimulation without FHR changes Show forest plot	3	192	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.23, 4.29]

12.7 Uterine rupture Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

12.8 Instrumental vaginal delivery Show forest plot	3	220	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.55, 2.57]

12.9 Meconium‐stained liquor Show forest plot	2	272	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.23, 1.21]

12.10 Apgar score < 7 at 5 minutes Show forest plot	2	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.14, 3.53]

12.11 Neonatal intensive care unit admission Show forest plot	3	372	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.32, 1.98]

12.12 Perinatal death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

12.13 Hemorrhagia postpartum Show forest plot	4	396	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.51, 3.11]

12.14 Maternal fever during labour Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.00]

12.15 Fetal distress Show forest plot	3	332	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.19, 0.98]

Comparison 12. Balloon (Foley or ATAD) versus oxytocin: all women

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Comparison 13. Balloon (Foley or ATAD) versus oxytocin: previous caesarean section

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
13.1 Caesarean section Show forest plot	3	364	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.64, 1.00]

13.2 Serious neonatal morbidity/perinatal death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

13.3 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Random, 95% CI)	Not estimable

Comparison 13. Balloon (Foley or ATAD) versus oxytocin: previous caesarean section

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Comparison 14. Balloon (Foley or ATAD) versus oxytocin: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
14.1 Caesarean section Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.12, 1.50]

14.2 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 14. Balloon (Foley or ATAD) versus oxytocin: all primiparae

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Comparison 15. Balloon (foley or ATAD) versus amniotomy: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
15.1 Caesarean section Show forest plot	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.03, 1.86]

Comparison 15. Balloon (foley or ATAD) versus amniotomy: all women

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Comparison 16. Single balloon (Foley) versus double balloon (ATAD/Cook): all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
16.1 Vaginal delivery not achieved in 24 hours Show forest plot	3	608	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.75, 1.25]

16.2 Uterine hyperstimulation with FHR changes Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

16.3 Caesarean section Show forest plot	5	862	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.71, 1.33]

16.4 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

16.5 Oxytcocin augmentation Show forest plot	2	278	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.82, 1.08]

16.6 Uterine hyperstimulation without FHR changes Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

16.7 Uterine rupture Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

16.8 Epidural analgesia Show forest plot	3	608	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.03]

16.9 Instrumental vaginal delivery Show forest plot	3	690	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.61, 1.20]

16.10 Meconium‐stained liquor Show forest plot	1	98	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.15, 1.04]

16.11 Apgar score < 7 at 5 minutes Show forest plot	3	608	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.25, 2.79]

16.12 Neonatal intensive care unit admission Show forest plot	2	391	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.71, 3.93]

16.13 Other maternal side‐effects: pain after insertion Show forest plot	1	74	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.20, 2.17]

16.14 Postpartum haemorrhage Show forest plot	2	291	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.27, 2.52]

16.15 Maternal fever during labour Show forest plot	3	584	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.16, 2.34]

16.16 Antibiotics during labour Show forest plot	1	217	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.61, 1.56]

16.17 Chorioamnionitis Show forest plot	1	98	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [0.47, 5.20]

16.18 Endometritis Show forest plot	1	217	Risk Ratio (M‐H, Fixed, 95% CI)	1.95 [0.18, 21.14]

16.19 Fetal distress Show forest plot	4	682	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.70, 1.36]

16.20 Umbilical artery pH < 7.10 Show forest plot	1	217	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.11, 1.57]

Comparison 16. Single balloon (Foley) versus double balloon (ATAD/Cook): all women

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Comparison 17. Single balloon (Foley) versus double balloon (ATAD): all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
17.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.95, 1.38]

17.2 Caesarean section Show forest plot	4	374	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.76, 2.22]

Comparison 17. Single balloon (Foley) versus double balloon (ATAD): all primiparae

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Comparison 18. Single balloon (Foley) versus double balloon (ATAD): all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
18.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	48	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.80, 1.93]

18.2 Caesarean section Show forest plot	2	186	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.30, 1.84]

Comparison 18. Single balloon (Foley) versus double balloon (ATAD): all multiparae

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Comparison 19. Laminaria tent versus vaginal prostaglandin E2: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
19.1 Uterine hyperstimulation with FHR changes Show forest plot	3	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.02, 0.60]

19.2 Caesarean section Show forest plot	5	263	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.56, 1.48]

19.3 Serious perinatal morbidity/perinatal death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

19.4 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

19.5 Uterine hyperstimulation without fetal heart rate changes Show forest plot	3	180	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.09, 0.49]

19.6 Epidural analgesia Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.74, 1.13]

19.7 Instrumental vaginal delivery Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.43, 1.17]

19.8 Meconium‐stained liquor Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.68]

19.9 Apgar score < 7 at 5 minutes Show forest plot	2	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

19.10 Perinatal death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

19.11 Maternal side effects: all Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.60]

19.12 Maternal nausea Show forest plot	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.60]

19.13 Fetal distress Show forest plot	3	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.34, 1.15]

Comparison 19. Laminaria tent versus vaginal prostaglandin E2: all women

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Comparison 20. Laminaria tent versus vaginal prostaglandin E2: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
20.1 Uterine hyperstimulation with FHR changes Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.95]

20.2 Caesarean section Show forest plot	2	90	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.24, 4.89]

Comparison 20. Laminaria tent versus vaginal prostaglandin E2: all primiparae

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Comparison 21. Laminaria tent versus vaginal prostaglandin E2: all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
21.1 Caesarean section Show forest plot	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.06, 3.91]

Comparison 21. Laminaria tent versus vaginal prostaglandin E2: all multiparae

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Comparison 22. Laminaria tent versus intracervical prostaglandin E2: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
22.1 Uterine hyperstimulation with FHR changes Show forest plot	2	350	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.02, 1.42]

22.2 Caesarean section Show forest plot	5	920	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.93, 1.45]

22.3 Serious neonatal morbidity/perinatal death Show forest plot	1	185	Risk Ratio (M‐H, Fixed, 95% CI)	3.16 [0.13, 76.70]

22.4 Serious maternal morbidity or death Show forest plot	1	185	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.52]

22.5 Cervix unfavourable/unchanged after 12‐24 hours Show forest plot	2	218	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.11, 1.96]

22.6 Oxytocin augmentation Show forest plot	1	185	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [1.21, 1.64]

22.7 Uterine hyperstimulation without FHR changes Show forest plot	2	601	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.02, 1.36]

22.8 Uterine rupture Show forest plot	1	185	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.52]

22.9 Instrumental vaginal delivery Show forest plot	3	424	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.65, 1.69]

22.10 Apgar score < 7 at 5 minutes Show forest plot	1	185	Risk Ratio (M‐H, Fixed, 95% CI)	5.28 [0.63, 44.30]

22.11 Neonatal intensive care unit admission Show forest plot	2	259	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.58, 4.33]

22.12 Perinatal death Show forest plot	1	185	Risk Ratio (M‐H, Fixed, 95% CI)	3.16 [0.13, 76.70]

22.13 Maternal side effects Show forest plot	1	165	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.15]

22.14 Postpartum haemorrhage Show forest plot	2	239	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.46, 2.81]

22.15 Chorioamnionitis Show forest plot	1	74	Risk Ratio (M‐H, Fixed, 95% CI)	3.17 [0.35, 29.06]

22.16 Endometritis Show forest plot	2	490	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.08, 1.09]

22.17 Fetal distress Show forest plot	2	128	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.07, 2.90]

Comparison 22. Laminaria tent versus intracervical prostaglandin E2: all women

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Comparison 23. Laminaria tent versus intracervical prostaglandin E2: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
23.1 Caesarean section Show forest plot	1	116	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.62, 2.13]

Comparison 23. Laminaria tent versus intracervical prostaglandin E2: all primiparae

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Comparison 24. Laminaria tent versus intracervical: prostaglandin E2 all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
24.1 Caesarean section Show forest plot	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.45, 3.65]

Comparison 24. Laminaria tent versus intracervical: prostaglandin E2 all multiparae

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Comparison 25. Laminaria tent versus oxytocin: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
25.1 Caesarean section Show forest plot	2	73	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.36, 1.89]

25.2 Fetal distress Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	2.69 [0.11, 63.18]

Comparison 25. Laminaria tent versus oxytocin: all women

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Comparison 26. Laminaria tent versus amniotomy: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
26.1 Caesarean section Show forest plot	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.22, 2.52]

Comparison 26. Laminaria tent versus amniotomy: all women

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Comparison 27. Laminaria tent versus other hygroscopic dilator: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
27.1 Caesarean section Show forest plot	1	41	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [0.44, 6.66]

Comparison 27. Laminaria tent versus other hygroscopic dilator: all women

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Comparison 28. EASI versus vaginal prostaglandin E2: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
28.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	1.74 [1.21, 2.49]

28.2 Uterine hyperstimulation with FHR changes Show forest plot	2	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.03, 2.07]

28.3 Caesarean section Show forest plot	2	221	Risk Ratio (M‐H, Fixed, 95% CI)	1.35 [0.94, 1.96]

28.4 Oxytocin augmentation Show forest plot	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	12.71 [3.20, 50.57]

28.5 Uterine hyperstimulation without fetal heart rate changes Show forest plot	2	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.03, 2.07]

28.6 Epidural analgesia Show forest plot	1	112	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.97, 1.04]

28.7 Instrumental vaginal delivery Show forest plot	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.30, 1.14]

28.8 Meconium‐stained liquor Show forest plot	1	112	Risk Ratio (M‐H, Fixed, 95% CI)	3.00 [0.12, 72.10]

28.9 Apgar score < 7 at 5 minutes Show forest plot	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	4.25 [0.21, 86.51]

28.10 Neonatal intensive care unit admission Show forest plot	1	112	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [0.45, 5.03]

28.11 Woman not satisfied Show forest plot	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.10, 3.25]

28.12 Fetal distress Show forest plot	1	112	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.39, 3.71]

Comparison 28. EASI versus vaginal prostaglandin E2: all women

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Comparison 29. EASI versus intracervical prostaglandin E2: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
29.1 Caesarean section Show forest plot	2	155	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.10, 5.12]

29.2 Cervix unfavourable/unchanged after 12‐24 hours Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.06 [0.00, 0.97]

29.3 Oxytocin augmentation Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.54, 2.25]

29.4 Instrumental vaginal delivery Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.01]

29.5 Apgar score < 7 at 5 minutes Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

29.6 Endometritis Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

29.7 Fetal distress Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.06, 1.28]

Comparison 29. EASI versus intracervical prostaglandin E2: all women

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Comparison 30. EASI versus intracervical prostaglandin E2: all primiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
30.1 Caesarean section Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.06, 1.09]

Comparison 30. EASI versus intracervical prostaglandin E2: all primiparae

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Comparison 31. Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
31.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.53, 1.33]

31.2 Uterine hyperstimulation with FHR changes Show forest plot	2	122	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.01, 5.12]

31.3 Caesarean section Show forest plot	7	517	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.66, 1.40]

31.4 Cervix unfavourable/unchanged after 24 hours Show forest plot	1	122	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.31, 0.85]

31.5 Oxytocin augmentation Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.64, 1.41]

31.6 Uterine hyperstimulation without FHR changes Show forest plot	3	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

31.7 Epidural analgesia Show forest plot	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.77, 1.24]

31.8 Instrumental vaginal delivery Show forest plot	2	78	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.22, 1.45]

31.9 Meconium‐stained liquor Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.33, 2.83]

31.10 Neonatal intensive care unit admission Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.01, 5.12]

31.11 Postpartum haemorrhage Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

31.12 Chorioamnionitis Show forest plot	2	122	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [0.45, 5.45]

31.13 Endometritis Show forest plot	3	237	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.41, 2.78]

31.14 Fetal distress Show forest plot	2	140	Risk Ratio (M‐H, Fixed, 95% CI)	2.28 [0.54, 9.69]

Comparison 31. Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women

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Comparison 32. Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
32.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.12, 0.82]

32.2 Caesarean section Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.58, 2.04]

32.3 Serious neonatal morbidity/perinatal death Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 3.90]

32.4 Cervix unfavourable/unchanged after 12‐24 hours Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.25, 0.67]

32.5 Oxytocin augmentation Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.01, 1.46]

32.6 Uterine hyperstimulation without FHR changes Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	4.05 [1.44, 11.38]

32.7 Instrumental vaginal delivery Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.77, 2.04]

32.8 Meconium‐stained liquor Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.23, 1.32]

32.9 Apgar score < 7 at 5 minutes Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.91 [0.18, 20.51]

32.10 Neonatal intensive care unit admission Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.31, 1.31]

32.11 Perinatal death Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 3.90]

32.12 Chorioamnionitis Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.91 [0.18, 20.51]

32.13 Endometritis Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.91 [0.36, 10.05]

Comparison 32. Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women

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Comparison 33. Any mechanical method and prostaglandin E2 versus oxytocin alone: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
33.1 Caesarean section Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.04, 2.47]

33.2 Instrumental vaginal delivery Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.12, 2.94]

33.3 Endometritis Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [0.15, 83.14]

Comparison 33. Any mechanical method and prostaglandin E2 versus oxytocin alone: all women

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Comparison 34. Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
34.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.89, 1.46]

34.2 Uterine hyperstimulation with FHR changes Show forest plot	1	327	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.27, 2.13]

34.3 Caesarean section Show forest plot	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.57, 1.25]

34.4 Serious neonatal morbidity/perinatal death Show forest plot	1	345	Risk Ratio (M‐H, Fixed, 95% CI)	2.04 [0.19, 22.24]

34.5 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

34.6 Oxytocin augmentation Show forest plot	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.34, 0.86]

34.7 Uterine hyperstimulation without fetal heart rate changes Show forest plot	1	327	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.22, 1.32]

34.8 Uterine rupture Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

34.9 Instrumental vaginal delivery Show forest plot	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.26, 3.98]

34.10 Meconium‐stained liquor Show forest plot	1	339	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.60, 2.23]

34.11 Apgar score < 7 at 5 minutes Show forest plot	1	346	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.25, 1.88]

34.12 Neonatal intensive care unit admission Show forest plot	1	346	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.12, 4.03]

34.13 Perinatal death Show forest plot	1	345	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.06, 16.14]

34.14 Maternal side effects Show forest plot	1	314	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.95, 1.43]

34.15 Maternal nausea Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	1.65 [0.98, 2.79]

34.16 Maternal diarrhoea Show forest plot	1	313	Risk Ratio (M‐H, Fixed, 95% CI)	3.72 [1.53, 9.00]

34.17 Postpartum haemorrhage Show forest plot	1	348	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.67, 1.41]

34.18 Serious maternal complications Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

34.19 Maternal fever during labour Show forest plot	1	347	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.26, 9.02]

Comparison 34. Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women

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Comparison 35. Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
35.1 Vaginal delivery not achieved in 24 hours Show forest plot	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.89, 1.46]

35.2 Uterine hyperstimulation with FHR changes Show forest plot	4	707	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.20, 1.45]

35.3 Caesarean section Show forest plot	6	1104	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.79, 1.17]

35.4 Serious neonatal morbidity/perinatal death Show forest plot	2	487	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.34, 4.55]

35.5 Serious maternal morbidity or death Show forest plot	2	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

35.6 Cervix unfavourable/unchanged after 12 hours Show forest plot	1	140	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.08, 0.94]

35.7 Oxytocin augmentation Show forest plot	4	733	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.66, 1.48]

35.8 Uterine hyperstimulation without FHR changes Show forest plot	3	664	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.26, 0.94]

35.9 Uterine rupture Show forest plot	2	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

35.10 Epidural analgesia Show forest plot	3	443	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.91, 1.10]

35.11 Instrumental vaginal delivery Show forest plot	3	676	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.58, 1.51]

35.12 Meconium‐stained liquor Show forest plot	5	925	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.26, 1.14]

35.13 Apgar score < 7 at 5 minutes Show forest plot	2	484	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.50, 2.43]

35.14 Neonatal intensive care unit admission Show forest plot	5	928	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.41, 1.55]

35.15 Perinatal death Show forest plot	1	347	Risk Ratio (M‐H, Fixed, 95% CI)	3.09 [0.13, 75.26]

35.16 Maternal side effects Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.87, 1.30]

35.17 Maternal nausea Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [0.84, 2.23]

35.18 Maternal diarrhoea Show forest plot	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	3.38 [1.40, 8.17]

35.19 Postpartum haemorrhage Show forest plot	2	466	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.65, 1.33]

35.20 Serious maternal complications Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

35.21 Chorioamnionitis Show forest plot	3	443	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.28, 1.38]

35.22 Endometrits Show forest plot	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.05, 5.84]

35.23 Fetal distress Show forest plot	3	466	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.61, 1.46]

Comparison 35. Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women

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Comparison 36. Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
36.1 Uterine hyperstimulation with FHR changes Show forest plot	1	151	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [0.55, 3.95]

36.2 Caesarean section Show forest plot	4	713	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.72, 1.20]

36.3 Serious maternal morbidity or death Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

36.4 Oxytocin augmentation Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	2.48 [1.95, 3.15]

36.5 Uterine hyperstimulation without FHR changes Show forest plot	1	151	Risk Ratio (M‐H, Fixed, 95% CI)	2.19 [1.39, 3.46]

36.6 Instrumental vaginal delivery Show forest plot	1	41	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.08, 1.58]

36.7 Meconium‐stained liquor Show forest plot	1	151	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.43, 2.95]

36.8 Apgar score < 7 at 5 minutes Show forest plot	1	151	Risk Ratio (M‐H, Fixed, 95% CI)	2.96 [0.12, 71.55]

36.9 Neonatal intensive care unit admission Show forest plot	1	151	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.30, 2.40]

36.10 Postpartum haemorrhage Show forest plot	1	151	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.68]

36.11 Endometritis Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

36.12 Fetal distress Show forest plot	3	498	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.61, 1.56]

Comparison 36. Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified)

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Comparison 37. Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
37.1 Vaginal delivery not achieved in 24 hours Show forest plot	2	362	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.37, 0.63]

37.2 Uterine hyperstimulation with FHR changes Show forest plot	3	1463	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.17, 1.11]

37.3 Caesarean section Show forest plot	5	1779	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.80, 1.12]

37.4 Serious neonatal morbidity/perinatal death Show forest plot	2	1263	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.18, 3.65]

37.5 Oxytocin augmentation Show forest plot	2	336	Risk Ratio (M‐H, Random, 95% CI)	3.89 [0.70, 21.72]

37.6 Uterine hyperstimulation without FHR changes Show forest plot	3	498	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.30, 0.92]

37.7 Epidural analgesia Show forest plot	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.90, 1.27]

37.8 Meconium‐stained liquor Show forest plot	2	362	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.43, 1.19]

37.9 Apgar score < 7 at 5 minutes Show forest plot	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.20, 4.58]

37.10 Neonatal intensive care unit admission Show forest plot	4	1599	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.49, 0.90]

37.11 Perinatal death Show forest plot	2	1263	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.18, 3.65]

37.12 Women not satisfied Show forest plot	1	866	Risk Ratio (M‐H, Fixed, 95% CI)	1.68 [1.47, 1.93]

37.13 Maternal fever Show forest plot	2	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.13 [0.04, 0.50]

37.14 Chorioamnionitis Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.32, 1.31]

37.15 Fetal distress Show forest plot	2	362	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.25, 1.21]

Comparison 37. Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified)

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Comparison 38. Any mechanical method and oxytocin versus low dose misoprostol alone: all multiparae

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
38.1 Caesarean section Show forest plot	1	136	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.19, 1.11]

Comparison 38. Any mechanical method and oxytocin versus low dose misoprostol alone: all multiparae

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Comparison 39. Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
39.1 Vaginal delivery not achieved in 24 hours Show forest plot	2	321	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.21, 2.40]

39.2 Caesarean section Show forest plot	6	718	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.39, 1.20]

39.3 Serious neonatal morbidity/perinatal death Show forest plot	2	321	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.12, 4.13]

39.4 Serious maternal morbidity or death Show forest plot	2	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

39.5 Uterine hyperstimulation without FHR changes Show forest plot	2	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.34, 2.09]

39.6 Uterine rupture Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

39.7 Epidural analgesia Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.98, 1.09]

39.8 Instrumental vaginal delivery Show forest plot	3	293	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.48, 2.02]

39.9 Meconium‐stained liquor Show forest plot	3	319	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.32, 1.63]

39.10 Neonatal intensive care unit admission Show forest plot	3	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.61, 1.58]

39.11 Postpartum haemorrhage Show forest plot	3	319	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.44, 3.18]

39.12 Serious maternal complications Show forest plot	1	0	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

39.13 Antibiotics during labour Show forest plot	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	2.32 [0.82, 6.55]

39.14 Chorionamnionitis Show forest plot	2	328	Risk Ratio (M‐H, Random, 95% CI)	4.34 [0.55, 34.01]

39.15 Endometritis Show forest plot	3	374	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.16, 7.45]

39.16 Fetal distress Show forest plot	3	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [0.68, 2.77]

Comparison 39. Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified)

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Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

PICO

PICO

Population

Intervention

Comparison

Outcome

Plain language summary

Mechanical methods for induction of labour

Resumen visual

Authors' conclusions

Implications for practice

Implications for research

Summary of findings

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Measures of effectiveness:

Complications:

Measures of satisfaction:

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

(1) Random sequence generation (checking for possible selection bias)

(2) Allocation concealment (checking for possible selection bias)

(3.1) Blinding of participants and personnel (checking for possible performance bias)

(3.2) Blinding of outcome assessment (checking for possible detection bias)

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

(5) Selective reporting (checking for reporting bias)

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

Measures of treatment effect

Dichotomous data

Continuous data

Unit of analysis issues

Cluster‐randomised trials

Cross‐over trials

Other unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Summary of findings and assessment of the certainty of the evidence

Results

Description of studies

Results of the search

Included studies

Design

Setting

Dates

Participants

Interventions and comparisons

1. Balloon comparisons

Outcomes

Source of trial funding