| Study characteristics |
| Methods |
Randomised controlled trial carried out in Israel. |
| Participants |
273 women with clinical or previous ultrasound suspicion of macrosomia, or with past history of macrosomia, underwent an ultrasound examination. Women were eligible if ultrasound estimated fetal weight, performed at 38 completed weeks or more, was between 4000 g and 4500 g. Women with diabetes, non‐cephalic presentation, previous caesarean section, or indication for labour induction other than macrosomia were excluded. 6 women in the induction of labour group and 3 in the expectant management group refused to participate after randomisation. 2 women in the expectant management group were lost to follow‐up. |
| Interventions |
Immediate induction of labour using either oxytocin or prostaglandins according to cervical status. Women in the expectant management group: labour was induced at 42 completed weeks of gestation unless fetal distress was suspected. |
| Outcomes |
Caesarean section, instrumental delivery, and spontaneous delivery.
Mean birthweight, mean arterial cord blood pH, shoulder dystocia, cephalohematoma, clavicular fracture, brachial plexus palsy, intraventricular haemorrhage.
Some results are given stratified according to parity. |
| Notes |
Additional information kindly provided by the authors. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Table of random numbers generated by computer. |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported. |
| 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 |
High risk |
Not reported, likely that outcome assessment was not blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All losses accounted for: 6 refused to participate in induction group and 3 in expectant group; 2 lost to follow‐up from expectant group; this left 273 women available for analysis: 134 in induction group and 139 in the expectant group. |
| Selective reporting (reporting bias) |
Low risk |
All expected outcome results reported. |
| Other bias |
Low risk |
Baseline characteristics similar between groups. No other bias apparent. |
