Boulvain 2015.

Study characteristics
Methods	Multi‐centre randomised controlled trial in collaboration with 19 teaching hospitals, members of GROG group, in France, Switzerland and Belguim. Recruitment 2002‐2009.
Participants	822 women randomised. Women with singleton fetus with cephalic presentation and no contraindications to vaginal delivery. Women were screened between 36‐38 weeks' gestation and those with a fetus with an estimated weight above the 95th percentile at 37 to 38 weeks of gestation, confirmed clinically and then by sonography were included. Exclusion criteria: any contraindication to induction of labour or vaginal delivery or a history of caesarean section, neonatal trauma or shoulder dystocia, severe urinary or faecal incontinence, or insulin treated diabetes.
Interventions	Intervention: 409 women allocated to induction of labour. Labour was induced between 37+0 and 38+6 weeks and within 3 days or randomisation. The method of induction was at the discretion of the attending physician and according to local protocol. Women with unfavourable cervix had cervical ripening with misoprostol or PGE2 followed by oxytocin infusion if labour had not started. Comparison group: 413 women allocated to expectant management. Women were managed expectantly until labour started spontaneously or the woman required induction (depending on local policy), for example, if PROM occurred or the pregnancy continued beyond 41 weeks.
Outcomes	The primary outcome was a composite outcome: significant shoulder dystocia, fracture of the clavicle or long bone, brachial plexus injury, intracranial haemorrhage or death. Significant shoulder dystocia was defined as difficulty with delivering the shoulders that was not resolved by the McRoberts’ manoeuvre (flexion of the maternal thighs usually combined with suprapubic pressure) or requiring other manoeuvres (Woods, Rubin or Jaquemier) to rotate the fetus to displace the fetal shoulder impacted behind the maternal pubic bone. The definition also included a delay of 60s or more between delivery of the head and the body. Secondary outcomes: mode of delivery, PPH (1000 mL or more), maternal blood transfusion, and anal sphincter tear, cord blood pH < 7.10, Apgar score < 7 at 5 minutes, admission to NICU, hyperbilirubinaemia (max value > 350 mmol/L).
Notes	2 of the authors of this review (MB and OI) were investigators on this trial; these author were not involved in data extraction or in assessing risk of bias for this study. Independent data extraction was carried out by other members of the review team.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation by centralised computer with permuted blocks (block size 4‐8) with stratification by centre.
Allocation concealment (selection bias)	Low risk	Central randomisation. Clinicians and participants had no access to the randomisation and women were randomised after consent had been obtained.
Blinding of participants and personnel (performance bias) All outcomes	High risk	It was not feasible to blind women or clinical staff to treatment allocation and lack of blinding may have affected clinical management and outcomes.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It was stated that the assessment of the primary outcome was by investigators masked to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There was very little attrition bias (822 women randomised 818 included in the analysis, 2 women in each group were lost to follow‐up).
Selective reporting (reporting bias)	Unclear risk	The trial recruited between 2002 and 2009. It was first registered in 2005 which was at the point recruitment expanded from 1 to 2 countries and from 4 to 19 hospitals, so fairly early in the overall recruitment numbers. There is also a trial protocol available in French. Both registry and protocol planned sample size was 1000. Instead recruitment ended due to financial constraints in Jan 2009 before any analyses were conducted. The published primary outcome “a composite of significant shoulder dystocia, fracture of the clavicle or a long bone, brachial plexus injury, intracranial haemorrhage, or death” includes two components “significant shoulder dystocia” and a delay of > 60 seconds between delivery of the head and body, was not mentioned in the registry but was set out in the protocol. For secondary outcomes, reduction of maternal morbidity and caesarean were mentioned in the registry and other secondary outcomes were pre‐specified in the protocol. The fetal secondary outcomes, CPAP, phototherapy and hypoglycaemia and the maternal secondaries, sepsis, fever (> 38.5 C) and retained placenta were not pre‐specified in either the registry or the protocol.
Other bias	Unclear risk	Baseline characteristics were similar between groups (although maternal weight gain appeared greater in the expectant management group (15.6 kg versus 14.7 kg).