Methods	RCT, 2-arm trial.
Participants	Setting: Los Angeles hospital, USA, 1996-2000 120 women with diabetes. Inclusion criteria: women with insulin dependent or other diabetes, gestational age 38 weeks (confirmed by ultrasound), not in labour, normal AFI (> 5 cm), normal FHR. Women compliant with hospital appointments and home glucose monitoring Exclusion criteria: women with multiple pregnancies, ruptured membranes, vaginal bleeding, prior uterine surgery, active genital herpes, glaucoma, serious medical disease, parity > 5, fetal weight > 4500 g or < 2000 g
Interventions	Study over 7 days. Intervention group: single dose of vaginal misoprostol 25 mcg Comparison group: placebo of similar appearance. Both groups were observed for 4 hrs and if there were no signs of fetal distress of painful contractions women were sent home. Reviewed after 3-4 days. If labour had not started then intervention/placebo was repeated. At 7 days women not in labour were induced
Outcomes	Additional induction agents required (oxytocin), mode of delivery, uterine hyperstimulation, neonatal condition at delivery
Notes
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Computer generated sequence.
Allocation concealment?	Yes	Coded drug boxes. Pharmacy prepared and distributed medication according to the randomisation schedule
Blinding? Women	Yes	Placebo controlled trial.
Blinding? Clinical staff	Yes
Blinding? Outcome assessor	Unclear	Not clear when code revealed.
Incomplete outcome data addressed? All outcomes	Unclear	120 women randomised and no loss to follow up was apparent but denominators in the data tables were not always clear
Free of other bias?	Yes