Methods	Placebo controlled RCT.
Participants	Setting: outpatient clinic in Memphis, USA. 100 women recruited. Inclusion criteria: gestation 38-40 weeks with Bishop score < 7 Exclusion criteria: non-reactive NST, oligohydramnios (AFI < 5.0 cm) macrosomia (> 4000 g or 10th centile), medical indication for delivery, more than 1 previous CS
Interventions	All women underwent NST, AFV and ultrasound assessment. Intervention group: 2 mg intravaginal PGE2 for 5 consecutive days Comparison group: identical placebo for 5 consecutive days. After each dose women were monitored for 30 min to rule out labour or fetal distress. Women were reviewed twice weekly (NST and AFV)
Outcomes	Other induction agents required, uterine hyperstimulation, CS, epidural, chorioamnionitis, Apgar score, NICU admission, gestational age at delivery
Notes
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Random number table. Permuted blocks with variable block size. The randomisation schedule was kept in pharmacy
Allocation concealment?	Yes	Coded drug boxes prepared by pharmacy.
Blinding? Women	Yes	Placebo controlled trial.
Blinding? Clinical staff	Yes
Incomplete outcome data addressed? All outcomes	Yes	State that “no post randomisation exclusions were allowed”. All women included in the analysis
Free of other bias?	Yes	No baseline imbalance apparent.