McKenna 2004.

Methods	RCT, 2 arm trial.
Participants	Setting: not clear. 68 women included. Inclusion criteria: women with "well‐dated" pregnancies with gestational age > 40 weeks and Bishop score < 9. Exclusion criteria: current indication for IOL, malpresentation, multiple pregnancy, previous CS, oligohydramnios (AFI < 5 cm). any contraindication to a trial of labour, current regular contractions.
Interventions	All women were assessed prior to randomisation. Intervention group: vaginal misoprostol 25 µg. Comparison group: placebo gel. Fetal and uterine monitoring for 1 h after treatment then women were discharged home. Labour was induced if BIshop score > 8 after 41 weeks or all women after 42 weeks.
Outcomes	Uterine hyperstimulation, mode of birth, epidural, Apgar score, NICU admission. (Women with PROM were given oxytocin to "stimulate labour" but were not included as inductions in the analyses.)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated sequence performed in hospital pharmacy.
Allocation concealment (selection bias)	Low risk	Placebo controlled trial.
Blinding (performance bias and detection bias) Women	Low risk	Placebo of similar appearance.
Blinding (performance bias and detection bias) Clinical staff	Unclear risk	Investigators blinded but other prenatal care providers aware of study participation.
Blinding (performance bias and detection bias) Outcome assessor	Unclear risk	Blinding of outcomes assessors not described. Obstetric staff aware of study participation. Birth and obstetric data taken from computerised records.
Incomplete outcome data (attrition bias) All outcomes	Low risk	68 women were randomised, 4 were excluded after randomisation and did not receive the study medication, but were included in an ITT analysis.
Selective reporting (reporting bias)	Unclear risk	Outcomes (apart from sample size calculation) not mentioned in methods text.
Other bias	Unclear risk	No baseline imbalance apparent.