Methods	RCT 2-arm parallel group design.
Participants	90 women attending 4 USA hospitals. Inclusion criteria: women with post-dates pregnancy (gestational age > 40 weeks + 3 days) attending for FHR testing. Gestation confirmed by ultrasound before 24 weeks, AFI > 5 cm, reactive NST Exclusion criteria: malpresentation, multiple pregnancy, previous CS, evidence of hyperstimulation or suspicious FHR patterns, grand multiparity (> 4 previous deliveries), placenta praevia or other contraindications to vaginal delivery
Interventions	Intervention group: intracervical PGE2 gel (Prepidil) 0.5 mg Comparison group: placebo gel. Gel was inserted by doctor or midwife in an antenatal testing centre or in the labour unit within rapid transport distance of delivery facilities. After insertion there was 40 min of continuous monitoring. Women returned to hospital after 3-4 days for fetal testing and further gel up to a max of 4 doses
Outcomes	Further induction agents required, CS rates, uterine hyperstimulation, FHR changes and side effects
Notes
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Computer generated sequence (permuted block design, but block size not stated)
Allocation concealment?	Yes	Central randomisation with coded drug boxes.
Blinding? Women	Yes	Unblinding was reported to occur only after completion of all the data collection
Blinding? Clinical staff	Yes
Blinding? Outcome assessor	Yes
Incomplete outcome data addressed? All outcomes	Yes	2 women that were randomised were not included in the analysis as they did not meet the inclusion criteria (the study was described as ITT)
Free of other bias?	Yes