Methods

Multicentre randomised equivalence trial.

Participants

Setting: 8 academic and 44 non‐academic hospitals in The Netherlands between November 2004 and November 2008.

Inclusion criteria: pregnant women between 36 + 0 and 41 + 0 weeks’ gestation who had a singleton fetus in cephalic presentation, suspected intrauterine growth restriction and who were under specialised obstetric care. Suspected intrauterine growth restriction was defined as fetal abdominal circumference below the 10th percentile, estimated fetal weight below the 10th percentile, flattening of the growth curve in the third trimester (as judged by a clinician), or the presence of all 3 factors.

Exclusion criteria: exclusion criteria were previous caesarean section, diabetes mellitus or gestational diabetes requiring insulin therapy, renal failure, HIV seropositivity, prelabour rupture of membranes, severe pre‐eclampsia, HELLP syndrome (haemolysis, elevated liver enzymes, and low platelet count), or a fetus with aneuploidy or congenital abnormalities suspected on ultrasound. Fetuses with decreased or absent movements, and those with abnormal heart rate tracings, were also excluded.

Number randomised: 650 women ‐ 321 to induction of labour and 329 to expectant management in overall study, which included women from 36 weeks' gestation. For this review data included term infants ≥ 37 weeks' gestation ‐ total 459 randomised ‐ 227 to induction of labour and 232 to expectant management.

Interventions

Induction of labour group: participants allocated to the induction of labour group were induced within 48 hours of randomisation. If the Bishop score at randomisation was greater than 6, labour was induced with amniotomy and, if necessary, augmented with oxytocin. Otherwise cervical ripening was performed with intracervical or intravaginal prostaglandin or a Foley balloon catheter.

Expectant management: women were monitored until the onset of spontaneous labour with daily fetal movement counts and twice‐weekly heart rate tracings, ultrasound examination, maternal blood pressure measurement, assessment of proteinuria, laboratory tests of liver and kidney function, and full blood count. Induction of labour or planned caesarean section was performed for obstetrical indications.

Outcomes

Primary: initial study: Composite measure of adverse neonatal outcome defined as death before hospital discharge, 5‐minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to neonatal intensive care.

Follow‐up study: 2‐year neurodevelopmental outcomes using ages and stages questionnaire and the child behaviour checklist.

Secondary: caesarean section, instrumental vaginal delivery, length of stay in the neonatal intensive care or neonatal ward, length of stay in the maternal hospital, and maternal morbidity (defined as postpartum haemorrhage of more than 1000 mL, development of gestational hypertension or pre‐eclampsia, eclampsia, pulmonary oedema, thromboembolism, or any other serious adverse event).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participant data were entered into a secure web‐based database. Women were randomly allocated to either induction or expectant monitoring in a 1:1 ratio using varied sized block randomisation with stratification for centre and parity.

Allocation concealment (selection bias)

Unclear risk

Secure web‐based database ‐ unclear whether centralised telephone allocation.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Complete outcome data reported and analysis by intention‐to‐treat.

Selective reporting (reporting bias)

Low risk

All pre‐specified outcomes reported on.

Other bias

Low risk

No apparent risk of other bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants and personnel not blinded, however, this is likely to be a low risk of bias secondary to the intervention being assessed.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors not blinded ‐ In initial study, primary outcomes not subject to bias, e.g. mortality, weight, gestational age, however in the follow‐up study there is potential for bias in the interpretation of the developmental measures used.

Methods

Prospective pilot RCT.

Participants

Setting: Department of Obstetrics and Gynaecology, Karolinska University Hospital, Huddinge, Sweden from late 1999 until spring 2001.

Inclusion criteria: patients referred at 41 completed weeks with uncomplicated pregnancies; amniotic fluid index < 50 mm.

Exclusion criteria: estimated fetal size < ‐22%; pathological umbilical artery blood flow; abnormal cardiotocograph.

Number randomised: 54 women, 26 to expectant management and 28 to induction of labour.

Interventions

Induction of labour: induction of labour was performed the same or following day. Patients with unfavourable cervix had a transcervical Foley catheter inserted for a maximum of 7 hours prior to amniotomy and oxytocin infusion, while patients with a favourable cervix primarily had amniotomy and oxytocin infusion.

Expectant management: no monitoring was done prior to spontaneous onset of labour. Those who did not go into labour spontaneously by 42 completed weeks were then managed according to department protocol.

Outcomes

Primary maternal: mode of delivery.

Secondary maternal: day at delivery.

Primary fetal: umbilical cord pH; Apgar score at 1, 5 and 10 minutes.

Secondary fetal: birthweight; number of admissions to the neonatal intensive care unit.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Patients were randomised, by sealed envelopes, after having given informed consent. No mention is made of how the randomisation sequence was generated.

Allocation concealment (selection bias)

Unclear risk

No mention is made as to how concealment was preserved. The information was stored in anonymous protocols at evaluation.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Trial was based on intention to treat. All patients completed the study and there were no treatment withdrawals.

Selective reporting (reporting bias)

Low risk

All pre‐specified outcomes reported on.

Other bias

Low risk

No apparent risk of other bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

This information was not provided however this is likely to be a low risk of bias secondary to the intervention being assessed.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

This information was not provided.

Methods

Pilot RCT.

Participants

Setting: Department of Obstetrics and Gynaecology, Atrium Medical Centre, Heerlen, The Netherlands between January 2002 and April 2004.

Inclusion criteria: pregnant women with suspected intrauterine growth restriction after 37 weeks’ gestation, based on clinical examination (measuring fundal height) and/or ultrasound biometry (fetal abdominal circumference (FAC) < 10th percentile or a declining FACcurve), singleton pregnancy; an accurate ultrasound dating scan performed before 20 weeks; a normal cardiotocograph; and doubt by the attending clinician whether to induce or to await spontaneous delivery.

Exclusion criteria: patients with multifetal pregnancies, uncertain gestational age, abnormal fetal presentations, or maternal diseases requiring induction of labour.

Number randomised: 33 consented to take part. 16 were allocated to the labour induction group, and 17 to await the spontaneous onset of labour.

Interventions

Patients were randomly allocated after stratification for parity to either induction of labour within 48 hours (labour induction group) or to await spontaneous onset of labour (expectant management group). Methods of labour induction were prostaglandin gel for cervical ripening and amniotomy and oxytocin intravenously according to local practice and individual preference. Participants allocated to the expectant management group were monitored with weekly measurement of the umbilical artery Doppler waveform and cardiotocography twice weekly. Additional monitoring was done if indicated. Labour was induced in the expectant management group if the clinician considered this necessary on the basis of changes in foetal or maternal condition.

Outcomes

Primary: obstetrical intervention rates and neonatal outcomes.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Patients were randomly allocated by drawing of a sealed opaque envelope. 2 series of envelopes, 1 for nulliparous and another for multiparous women, were filled at random by a statistician with a folded paper ‘‘induction’’ or ‘‘expectation’’ and numbered consecutively. The envelopes were opened in sequence of numbers in presence of the patient. No envelope was missed.

Allocation concealment (selection bias)

Low risk

Sealed opaque envelopes were used.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Analyses were performed by intention‐to‐treat. All patients completed the study and there were no treatment withdrawals.

Selective reporting (reporting bias)

Low risk

The primary outcomes were reported.

Other bias

Low risk

No apparent risk of other bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

This information was not provided however this is likely to be a low risk of bias secondary to the intervention being assessed.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

This information was not provided.