Study characteristics |
Methods |
Randomised controlled trial carried out in two centres in the UK. |
Participants |
59 women (30 induction; 29 await spontaneous labour) with a fetus estimated above the 97th percentile (abdominal circumference, estimated fetal weight according to Chitty 1994). |
Interventions |
Immediate induction of labour using either oxytocin or prostaglandins. Women in the expectant management group: labour was induced at 42 completed weeks of gestation. |
Outcomes |
Mode of delivery, birthweight, delay and adverse maternal or neonatal outcome. |
Notes |
No adverse fetal or maternal outcome. Standard deviation estimated from the information available (interquartile ranges). |
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) |
Low risk |
Sealed opaque, consecutively‐numbered envelopes. |
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; it is likely that outcome assessment was not blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
29/30 women in the induction group had induction, compared to 14/29 in the expectant management group; analysis was however performed on an intention‐to‐treat basis. |
Selective reporting (reporting bias) |
Unclear risk |
Not possible to tell ‐ unpublished data. |
Other bias |
Unclear risk |
Unclear. |