Methods	RCT.
Participants	Setting: USA, naval medical centre. 50 women. Inclusion criteria: women with prolonged pregnancy (41-42 weeks’ gestation) confirmed by ultrasound, clinical examination and menstrual dates. Singleton, cephalic presentation, intact membranes, Bishop score < 5, < 8 contractions per hour, AFI > 5 cm, reactive NST, maternal age > 18, < 50 Exclusion criteria: malpresentations, multiple pregnancy, previous CS, vaginal bleeding, ruptured membranes, non reactive NST, estimated fetal weight > 4500 g or < 2000 g, placenta previa, active herpes, hypersensitivity to prostaglandin, signs of infection, asthma or serious disease
Interventions	Intervention group: vaginal misoprostol 25 mcg. (with 2nd dose after 24 hrs.) Comparison group: placebo, packaged and labelled to appear indistinguishable Both groups were observed for 4 hrs with FHR and uterine activity monitoring. If women showed no sign of labour of fetal distress they were discharged and asked to return after 24 hrs for a second dose, then review after a further 24 hrs for inpatient management
Outcomes	Uterine hyperstimulation, CS, Apgar score < 7 at 5 min, meconium staining
Notes
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Computer generated sequence by pharmacy (permuted block design)
Allocation concealment?	Yes	The list was maintained by inpatient pharmacy and drugs were dispensed to appear identical
Blinding? Women	Yes	Placebo controlled trial.
Blinding? Clinical staff	Yes
Blinding? Outcome assessor	Yes
Incomplete outcome data addressed? All outcomes	Yes	No apparent loss to follow up.

AFI: amniotic fluid index

AFV: amniotic fluid volume

CS: caesarean section

EDD: expected date of delivery

FGR: fetal growth retardation

FHR: fetal heart rate

hrs: hours

IMN: isosorbide mononitrate

IOL: induction of labour

ITT: intention to treat

max: maximum

min: minutes

NHS: National Health Service (UK)

NICU: neonatal intensive care unit

NST: non-stress test

PPH: postpartum haemorrhage

PROM: premature rupture of the membranes

RCT: randomised controlled trial

vs: versus