Methods of term labour induction for women with a previous caesarean section

Helen M West; Marta Jozwiak; Jodie M Dodd

doi:10.1002/14651858.CD009792.pub3

Cochrane Database of Systematic Reviews

Méthodes de déclenchement d’accouchement à terme pour les femmes ayant précédemment accouché par césarienne

Información

DOI:

https://doi.org/10.1002/14651858.CD009792.pub3 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

09 junio 2017see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Embarazo y parto

Copyright:

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Helen M West

Institute of Psychology, Health and Society, The University of Liverpool, Liverpool, UK
Marta Jozwiak

Correspondencia a: Leiden University Medical Center, Leiden, Netherlands

[email protected]
Jodie M Dodd

School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, Adelaide, Australia

Contributions of authors

For the review update, Helen West and Marta Jozwiak assessed study eligibility, methodological quality, and performed data extraction. Helen West entered the data, conducted the GRADE assessment, produced the 'Summary of findings' tables, and drafted the review update. Jodie Dodd checked the data and commented on the review.

Sources of support

Internal sources

(HW) Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health, The University of Liverpool, Liverpool, UK.

External sources

The University of Adelaide, Discipline of Obstetrics and Gynaecology, Australia.
The Australian National Health and Medical Research Council Practitioner Fellowship, Australia.
(HW) NIHR Cochrane Programme Grant Project: 13/89/05 – Pregnancy and childbirth systematic reviews to support clinical guidelines, UK.

Declarations of interest

Jodie Dodd: none known.

Marta Jozwiak was involved in two RCTs on the topic of induction of labour but these are not eligible for inclusion in this review (the participants had not had a previous caesarean section). She was also involved in an observational study looking at induction of labour in women with a caesarean section (PROBAAT‐S study) – this study has not yet been published but would not be eligible for inclusion in this review as it is not a randomised controlled trial.

Helen West's contribution to this project was supported by the National Institute for Health Research, via Cochrane Programme Grant funding to Cochrane Pregnancy and Childbirth. NIHR has no influence on the content or conclusions of this review.

Acknowledgements

Helen West is supported by the National Institute for Health Research (NIHR) Cochrane Programme Grant Project: 13/89/05 – Pregnancy and childbirth systematic reviews to support clinical guidelines.

Anna Cuthbert for data extraction; Denise Atherton for administrative assistance; Lynn Hampson for the literature search.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure and Cochrane Programme Grant funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2017 Jun 09

Methods of term labour induction for women with a previous caesarean section

Review

Helen M West, Marta Jozwiak, Jodie M Dodd

https://doi.org/10.1002/14651858.CD009792.pub3

2013 Mar 28

Methods of term labour induction for women with a previous caesarean section

Review

Marta Jozwiak, Jodie M Dodd

https://doi.org/10.1002/14651858.CD009792.pub2

2012 Apr 18

Methods of term labour induction for women with a previous caesarean section

Protocol

Marta Jozwiak, Jodie M Dodd

https://doi.org/10.1002/14651858.CD009792

Differences between protocol and review

We have updated our methods to include the use of GRADE to assess the quality of the body of evidence and we have included 'Summary of findings' tables.

Trials using a cluster‐RCT design are now eligible for inclusion in this review (and we include methods for dealing with them) but none were identified for this update. We also include methods for dealing with trials that have multiple‐arms.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Pregnancy;

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.

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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Analysis 1.1

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 1 Caesarean section.

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Analysis 1.2

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 2 Serious neonatal morbidity or perinatal death.

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Analysis 1.3

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 3 Serious maternal morbidity or death.

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Analysis 1.4

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 4 Uterine rupture.

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Analysis 1.5

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 5 Epidural analgesia.

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Analysis 1.6

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 6 Instrumental vaginal delivery.

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Analysis 1.7

Comparison 1 Vaginal PGE2 versus intravenous oxytocin, Outcome 7 Apgar score < 7 at 5 minutes.

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Analysis 2.1

Comparison 2 Vaginal misoprostol versus intravenous oxytocin, Outcome 1 Uterine rupture.

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Analysis 3.1

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 1 Vaginal delivery not achieved within 24 hours.

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Analysis 3.2

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 2 Uterine hyperstimulation with FHR changes.

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Analysis 3.3

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 3 Caesarean section.

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Analysis 3.4

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 4 Oxytocin augmentation.

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Analysis 3.5

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 5 Uterine rupture.

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Analysis 3.6

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 6 Instrumental vaginal delivery.

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Analysis 3.7

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 7 Postpartum haemorrhage.

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Analysis 3.8

Comparison 3 Foley catheter versus intravenous oxytocin, Outcome 8 Chorioamnionitis.

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Analysis 4.1

Comparison 4 Double‐balloon catheter versus vaginal PGE2, Outcome 1 Caesarean section.

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Analysis 4.2

Comparison 4 Double‐balloon catheter versus vaginal PGE2, Outcome 2 Admission to neonatal unit.

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Analysis 5.1

Comparison 5 Oral mifepristone versus Foley catheter, Outcome 1 Oxytocin augmentation.

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Analysis 5.2

Comparison 5 Oral mifepristone versus Foley catheter, Outcome 2 Uterine rupture.

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Analysis 6.1

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 1 Vaginal delivery not achieved within 24 hours.

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Analysis 6.2

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 2 Caesarean section.

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Analysis 6.3

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 3 Oxytocin augmentation.

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Analysis 6.4

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 4 Uterine rupture.

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Analysis 6.5

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 5 Epidural analgesia.

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Analysis 6.6

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 6 Instrumental vaginal delivery.

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Analysis 6.7

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 7 Meconium‐stained liquor.

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Analysis 6.8

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 8 Apgar score < 7 at 5 minutes.

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Analysis 6.9

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 9 Neonatal intensive care unit admission.

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Analysis 6.10

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 10 Maternal nausea and vomiting.

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Analysis 6.11

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 11 Puerperal pyrexia (other maternal side‐effects).

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Analysis 6.12

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 12 Palpitation (other maternal side‐effects).

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Analysis 6.13

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 13 Headache (other maternal side‐effects).

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Analysis 6.14

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 14 Postpartum haemorrhage.

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Analysis 6.15

Comparison 6 Vaginal isosorbide mononitrate versus Foley catheter, Outcome 15 Woman not satisfied.

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Analysis 7.1

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 1 Vaginal delivery not achieved within 24 hours.

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Analysis 7.2

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 2 Caesarean section.

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Analysis 7.3

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 3 Oxytocin augmentation.

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Analysis 7.4

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 4 Uterine rupture.

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Analysis 7.5

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 5 Epidural analgesia.

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Analysis 7.6

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 6 Instrumental vaginal delivery.

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Analysis 7.7

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 7 Apgar score < 7 at 5 minutes.

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Analysis 7.8

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 8 Neonatal intensive care unit admission.

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Analysis 7.9

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 9 Neonatal encephalopathy.

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Analysis 7.10

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 10 Perinatal death.

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Analysis 7.11

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 11 Neonatal infection.

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Analysis 7.12

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 12 Cord prolapse (other maternal side‐effects).

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Analysis 7.13

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 13 Postpartum haemorrhage.

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Analysis 7.14

Comparison 7 Foley catheter 80 mL versus Foley catheter 30 mL, Outcome 14 Chorioamnionitis.

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Analysis 8.1

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 1 Caesarean section.

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Analysis 8.2

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 2 Oxytocin augmentation.

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Analysis 8.3

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 3 Uterine hyperstimulation (FHR change not mentioned).

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Analysis 8.4

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 4 Uterine rupture.

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Analysis 8.5

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 5 Apgar score < 7 at 5 minutes.

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Analysis 8.6

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 6 Neonatal intensive care unit admission.

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Analysis 8.7

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 7 Neonatal infection.

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Analysis 8.8

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 8 Postpartum haemorrhage.

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Analysis 8.9

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 9 Chorioamnionitis.

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Analysis 8.10

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 10 Endometritis.

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Analysis 8.11

Comparison 8 Vaginal PGE2 pessary versus vaginal PGE2 tablet, Outcome 11 Maternal intensive care unit admission (serious maternal complications).

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Summary of findings for the main comparison. Vaginal PGE2 versus intravenous (IV) oxytocin

Vaginal PGE2 compared with IV oxytocin for term labour induction for women with a previous caesarean section
Patient or population: women with one previous lower segment caesarean section and requiring labour induction due to prolonged pregnancy or pre‐eclampsia, singleton in cephalic presentation, GA ≥ 37 weeks, BS < 9, no cephalopelvic disproportion anticipated Setting: UK Intervention: vaginal prostaglandin E2 (2.5 mg pessary) Comparison: intravenous oxytocin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with oxytocin	Risk with prostaglandin E2
Vaginal delivery not achieved within 24 hours	‐	‐	‐	‐	‐	Not reported
Uterine hyperstimulation with fetal heart rate changes	‐	‐	‐	‐	‐	Not reported
Caesarean section	Study population		RR 0.67 (0.22 to 2.03)	42 (1 RCT)	⊕⊕⊝⊝ Low¹
	286 per 1000	191 per 1000 (63 to 580)
Serious neonatal morbidity/perinatal death	Study population		RR 3.00 (0.13 to 69.70)	42 (1 RCT)	⊕⊕⊝⊝ Low¹
	0 per 1000	0 per 1000 (0 to 0)
Serious maternal morbidity or death	Study population		RR 3.00 (0.13 to 69.70)	42 (1 RCT)	⊕⊕⊝⊝ Low¹
	0 per 1000	0 per 1000 (0 to 0)
*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). BS: Bishop score; CI: Confidence interval; GA: gestational age; RR: Risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
¹Wide CI crossing the line of no effect, small sample size, and few events (imprecision, downgraded 2 levels).

Summary of findings for the main comparison. Vaginal PGE2 versus intravenous (IV) oxytocin

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Summary of findings 2. Vaginal misoprostol versus intravenous (IV) oxytocin

Vaginal misoprostol compared with IV oxytocin for term labour induction for women with a previous caesarean section
Patient or population: women with a previous caesarean section Setting: USA Intervention: vaginal misoprostol 25 μg every 6 hours (maximum of 4 doses) Comparison: intravenous oxytocin "per a standardised infusion protocol" see Wing 1998 (dose/regime not reported)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with misoprostol	Risk with oxytocin	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Vaginal delivery not achieved within 24 hours						not reported
Uterine hyperstimulation with fetal heart rate changes						not reported
Caesarean section						not reported
Serious neonatal morbidity or perinatal death						not reported
Serious maternal morbidity or death						not reported
*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 quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

Summary of findings 2. Vaginal misoprostol versus intravenous (IV) oxytocin

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Summary of findings 3. Foley catheter versus intravenous (IV) oxytocin

Foley catheter compared with IV oxytocin for term labour induction for women with a previous caesarean section
Patient or population: pregnant women with a previous low transverse caesarean section, singleton live pregnancy with cephalic presentation, period of gestation > 28 weeks and BS < 5 were included in the study, with unfavourable cervix Setting: Chandigarh, India. July 2004–November 2005 Intervention: Foley catheter balloon inflated with 30 mL of sterile saline Comparison: intravenous oxytocin (low dose IV oxytocin, starting at 1 mU/min and increasing if contractions were not frequent after 1 hour)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with oxytocin	Risk with Foley catheter
Vaginal delivery not achieved within 24 hours	Study population		RR 1.47 (0.89 to 2.44)	53 (1 RCT)	⊕⊕⊝⊝ Low¹
	444 per 1000	653 per 1000 (396 to 1000)
Uterine hyperstimulation with fetal heart rate changes	Study population		RR 3.11 (0.13 to 73.09)	53 (1 RCT)	⊕⊕⊝⊝ Low¹
	0 per 1000	0 per 1000 (0 to 0)
Caesarean section	Study population		RR 0.93 (0.45 to 1.92)	53 (1 RCT)	⊕⊕⊝⊝ Low¹
	370 per 1000	344 per 1000 (167 to 711)
Serious neonatal morbidity or perinatal death	‐	‐	‐	‐	‐	Not reported
Serious maternal morbidity or death	‐	‐	‐	‐	‐	Not reported
*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). BS: Bishop score; CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
¹Wide confidence interval crossing the line of no effect, small sample size, and few events (imprecision, downgraded 2 levels).

Summary of findings 3. Foley catheter versus intravenous (IV) oxytocin

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Summary of findings 4. Double‐balloon catheter versus vaginal PGE2

Double‐balloon catheter compared with vaginal PGE2 for term labour induction for women with a previous caesarean section
Patient or population: women with a previous caesarean section (subgroup of all women in the study) with intact fetal membranes, cephalic position and unfavourable cervix, with indications for induction of labour Setting: 7 labour wards in Denmark, December 2002‐September 2005 Intervention: double‐balloon catheter inserted through the cervical canal with 80 mL of saline installed stepwise in the uterine balloon and 80 mL saline in the cervicovaginal balloon Comparison: vaginal prostaglandin E2 (dinoprostone 3 mg vaginal tablet)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with prostaglandin E2	Risk with double‐balloon catheter
Vaginal delivery not achieved within 24 hours	‐	‐	‐	‐	‐	Not reported
Uterine hyperstimulation with fetal heart rate changes	‐	‐	‐	‐	‐	Not reported
Caesarean section	Study population		RR 0.97 (0.41 to 2.32)	16 (1 RCT)	⊕⊝⊝⊝ Very low^{1, 2}
	571 per 1000	554 per 1000 (234 to 1000)
Serious neonatal morbidity or perinatal death	‐	‐	‐	‐	‐	Not reported
Serious maternal morbidity or death	‐	‐	‐	‐	‐	Not reported
*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 quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
¹One study with design limitations (risk of bias, downgraded 1 level). ²Wide confidence interval crossing the line of no effect, small sample size, and few events (imprecision, downgraded 2 levels).

Summary of findings 4. Double‐balloon catheter versus vaginal PGE2

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Summary of findings 5. Oral mifepristone versus Foley catheter

Oral mifepristone compared with Foley catheter for term labour induction for women with a previous caesarean section
Patient or population: pregnant women, 40 weeks' gestation, single cephalic presentation, 1 previous low segment caesarean section Setting: India, 2012‐2014 Intervention: oral mifepristone (400 mg) orally at 40 + 5. All women were reassessed 24 hours and 48 hours later. If BS > 6, amniotomy was performed, followed by oxytocin infusion. If after 48 hours, BS was < 6, induction of labour was done with oxytocin infusion Comparison: Foley catheter with 30 mL normal saline inserted at 40 + 5
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with mifepristone	Risk with Foley catheter	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Vaginal delivery not achieved within 24 hours						not reported
Uterine hyperstimulation with fetal heart rate changes						not reported
Caesarean section						not reported
Serious neonatal morbidity or perinatal death						not reported
Serious maternal morbidity or death						not reported
*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). BS: Bishop score; CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

Summary of findings 5. Oral mifepristone versus Foley catheter

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Summary of findings 6. Vaginal isosorbide mononitrate versus Foley catheter

Vaginal isosorbide mononitrate versus Foley catheter for term labour induction for women with a previous caesarean section
Patient or population: pregnant women with 1 previous lower segment caesarean section at 37 weeks and beyond, with a BS of ≤ 6, intact membranes, reactive non‐stress test, normal umbilical arterial Doppler indices, absence of labour and willingness of women to participate in the study Setting: Egypt Intervention: vaginal isosorbide mononitrate (40 mg) inserted into the posterior fornix of the vagina once Comparison: Foley catheter No. 14‐16 Fr inserted into the endocervical canal, beyond the internal os and inflated with 50‐60 mL of normal saline
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with Foley catheter	Risk with isosorbide mononitrate
Vaginal delivery not achieved within 24 hours	Study population		RR 2.63 (1.32 to 5.21)	80 (1 RCT)	⊕⊕⊝⊝ Low^{1, 2}
	200 per 1000	526 per 1000 (264 to 1000)
Uterine hyperstimulation with fetal heart rate changes	‐	‐	‐	‐	‐	Not reported
Caesarean section	Study population		RR 1.00 (0.39 to 2.59)	80 (1 RCT)	⊕⊝⊝⊝ Very low^{1, 3}
	175 per 1000	175 per 1000 (68 to 453)
Serious neonatal morbidity or perinatal death	‐	‐	‐	‐	‐	Not reported
Serious maternal morbidity or death	‐	‐	‐	‐	‐	Not reported
*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). BS: Bishop score; CI: Confidence interval; Fr: French; RR: Risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
¹ One study with design limitations (risk of bias, downgraded 1 level). ² Small sample size (imprecision, downgraded 1 level). ³ Wide CI crossing the line of no effect, small sample size (imprecision, downgraded 2 levels).

Summary of findings 6. Vaginal isosorbide mononitrate versus Foley catheter

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Summary of findings 7. 80 mL versus 30 mL Foley catheter

80 mL Foley catheter versus 30 mL Foley catheter for term labour induction for women with a previous caesarean section
Patient or population: pregnant women who previously had a lower segment CS and now have a singleton cephalic presentation after at least 36 completed weeks, not in labour, with intact membranes and BS of < 6 Setting: a large tertiary centre in South India, which carries out ˜15,000 deliveries every year. October 2011‐December 2013 Intervention: a 16 Fr Foley catheter was introduced into the cervix beyond the internal os and the bulb inflated with 80 mL of sterile water Comparison: a 16 Fr Foley catheter was introduced into the cervix beyond the internal os and the bulb inflated with 30 mL of sterile water
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with 30 mL Foley catheter	Risk with 80 mL Foley catheter
Vaginal delivery not achieved within 24 hours	Study population		RR 1.05 (0.91 to 1.20)	154 (1 RCT)	⊕⊕⊕⊝ Moderate¹
	818 per 1000	859 per 1000 (745 to 982)
Uterine hyperstimulation with fetal heart rate changes	‐	‐	‐	‐	‐	Not reported
Caesarean section	Study population		RR 1.05 (0.89 to 1.24)	154 (1 RCT)	⊕⊕⊕⊝ Moderate¹
	766 per 1000	805 per 1000 (682 to 950)
Serious neonatal morbidity or perinatal death	‐	‐	‐	‐	‐	Not reported
Serious maternal morbidity or death	‐	‐	‐	‐	‐	Not reported
*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). BS: Bishop score; CI: Confidence interval; Fr: French; RR: Risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
¹Small sample size (imprecision, downgraded 1 level).

Summary of findings 7. 80 mL versus 30 mL Foley catheter

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Summary of findings 8. Vaginal PGE2 pessary versus vaginal PGE2 tablet

Vaginal PGE2 pessary versus vaginal PGE2 tablet for term labour induction for women with a previous caesarean section
Patient or population: women with a previous caesarean section, a live singleton fetus (37‐42 weeks of gestation) in cephalic presentation and a reactive non‐stress test, BS of ≤ 7 before onset of labour, no spontaneous contractions (< 4 contractions within 20 minutes) Setting: large Governmental hospital, Saudi Arabia. February 2009‐March 2013 Intervention: vaginal PGE2 pessary (10 mg dinoprostone sustained‐release vaginal pessary) Comparison: vaginal PGE2 tablet (1.5 mg dinoprostone vaginal tablet)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with dinoprostone tablet	Risk with dinoprostone pessary
Vaginal delivery not achieved within 24 hours	‐	‐	‐	‐	‐	Not reported
Uterine hyperstimulation with fetal heart rate changes	‐	‐	‐	‐	‐	Not reported
Caesarean section	Study population		RR 1.09 (0.74 to 1.60)	200 (1 RCT)	⊕⊝⊝⊝ Very low^{1, 2}
	330 per 1000	360 per 1000 (244 to 528)
Serious neonatal morbidity or perinatal death	‐	‐	‐	‐	‐	Not reported
Serious maternal morbidity or death	‐	‐	‐	‐	‐	Not reported
*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). BS: Bishop score; CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
¹One study with design limitations (risk of bias, downgraded 1 level). ²Wide confidence crossing the line of no effect, small sample size (imprecision, downgraded 2 levels).

Summary of findings 8. Vaginal PGE2 pessary versus vaginal PGE2 tablet

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Comparison 1. Vaginal PGE2 versus intravenous oxytocin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Caesarean section Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.22, 2.03]

2 Serious neonatal morbidity or perinatal death Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 69.70]

3 Serious maternal morbidity or death Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 69.70]

4 Uterine rupture Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 69.70]

5 Epidural analgesia Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.93, 2.17]

6 Instrumental vaginal delivery Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.39, 4.02]

7 Apgar score < 7 at 5 minutes Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Vaginal PGE2 versus intravenous oxytocin

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Comparison 2. Vaginal misoprostol versus intravenous oxytocin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Uterine rupture Show forest plot	1	38	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [0.16, 84.66]

Comparison 2. Vaginal misoprostol versus intravenous oxytocin

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Comparison 3. Foley catheter versus intravenous oxytocin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Vaginal delivery not achieved within 24 hours Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	1.47 [0.89, 2.44]

2 Uterine hyperstimulation with FHR changes Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	3.11 [0.13, 73.09]

3 Caesarean section Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.45, 1.92]

4 Oxytocin augmentation Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.81, 1.32]

5 Uterine rupture Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

6 Instrumental vaginal delivery Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	7.26 [0.39, 134.01]

7 Postpartum haemorrhage Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	3.11 [0.13, 73.09]

8 Chorioamnionitis Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Foley catheter versus intravenous oxytocin

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Comparison 4. Double‐balloon catheter versus vaginal PGE2

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Caesarean section Show forest plot	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.41, 2.32]

2 Admission to neonatal unit Show forest plot	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Double‐balloon catheter versus vaginal PGE2

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Comparison 5. Oral mifepristone versus Foley catheter

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Oxytocin augmentation Show forest plot	1	107	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.38, 0.76]

2 Uterine rupture Show forest plot	1	107	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.08, 1.02]

Comparison 5. Oral mifepristone versus Foley catheter

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Comparison 6. Vaginal isosorbide mononitrate versus Foley catheter

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Vaginal delivery not achieved within 24 hours Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	2.63 [1.32, 5.21]

2 Caesarean section Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.39, 2.59]

3 Oxytocin augmentation Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	1.65 [1.17, 2.32]

4 Uterine rupture Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

5 Epidural analgesia Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.39, 2.59]

6 Instrumental vaginal delivery Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.23, 2.76]

7 Meconium‐stained liquor Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.19, 21.18]

8 Apgar score < 7 at 5 minutes Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.95, 2.93]

9 Neonatal intensive care unit admission Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.51, 12.14]

10 Maternal nausea and vomiting Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.33, 27.63]

11 Puerperal pyrexia (other maternal side‐effects) Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.16, 1.07]

12 Palpitation (other maternal side‐effects) Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.51, 12.14]

13 Headache (other maternal side‐effects) Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	3.33 [0.99, 11.22]

14 Postpartum haemorrhage Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.90, 4.43]

15 Woman not satisfied Show forest plot	1	80	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.56, 5.51]

Comparison 6. Vaginal isosorbide mononitrate versus Foley catheter

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Comparison 7. Foley catheter 80 mL versus Foley catheter 30 mL

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Vaginal delivery not achieved within 24 hours Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.91, 1.20]

2 Caesarean section Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.89, 1.24]

3 Oxytocin augmentation Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.66, 0.98]

4 Uterine rupture Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.06, 15.70]

5 Epidural analgesia Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

6 Instrumental vaginal delivery Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.43, 1.95]

7 Apgar score < 7 at 5 minutes Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.06, 15.70]

8 Neonatal intensive care unit admission Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.19, 21.60]

9 Neonatal encephalopathy Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.12, 72.52]

10 Perinatal death Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.12, 72.52]

11 Neonatal infection Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

12 Cord prolapse (other maternal side‐effects) Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

13 Postpartum haemorrhage Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.06]

14 Chorioamnionitis Show forest plot	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.13]

Comparison 7. Foley catheter 80 mL versus Foley catheter 30 mL

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Comparison 8. Vaginal PGE2 pessary versus vaginal PGE2 tablet

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Caesarean section Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.74, 1.60]

2 Oxytocin augmentation Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.81, 2.78]

3 Uterine hyperstimulation (FHR change not mentioned) Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.05, 5.43]

4 Uterine rupture Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.09]

5 Apgar score < 7 at 5 minutes Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.22, 2.89]

6 Neonatal intensive care unit admission Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.17, 3.27]

7 Neonatal infection Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.06, 15.77]

8 Postpartum haemorrhage Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.14, 6.96]

9 Chorioamnionitis Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.06, 15.77]

10 Endometritis Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.26, 8.79]

11 Maternal intensive care unit admission (serious maternal complications) Show forest plot	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 8. Vaginal PGE2 pessary versus vaginal PGE2 tablet

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Méthodes de déclenchement d’accouchement à terme pour les femmes ayant précédemment accouché par césarienne

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