Kipikasa 2005.

Methods	RCT 2‐arm parallel group design (dose comparison study).
Participants	52 women attending a large teaching hospital and scheduled for IOL. Inclusion criteria: singleton, cephalic presentation, not in active labour, gestational age > 40 weeks (confirmed by menstrual dates and ultrasound before 20 weeks). Exclusion criteria: previous CS, FHR abnormalities, contraindication to prostaglandin or vaginal birth.
Interventions	Intervention group: 50 µg oral misoprostol. Comparison group: 25 µg misoprostol. Prior to randomisation women received an ultrasound to assess fetal growth and AFV and a fetal NST was carried out. In both groups medication was administered by a nurse and in the absence of labour or contraindications the dose was repeated after 3 days to a maximum of 3 doses over 9 days. Women returned to hospital every 3 days unless labour started or there was any reduction in fetal kicks.
Outcomes	Days to birth, uterine hyperstimulation, further induction agents required, CS, Apgar score < 6 at 5 min, NICU admission, meconium staining, perinatal death.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated sequence.
Allocation concealment (selection bias)	Low risk	Coded drug boxes.
Blinding (performance bias and detection bias) Women	Unclear risk	Intervention and placebo tablets were cut from larger tablets (1/4 or 1/8) and described as appearing the same.
Blinding (performance bias and detection bias) Clinical staff	Unclear risk	Staff were said to be blinded because placebo and intervention tablets indistinguishable. We were unsure if they were indistinguishable to knowledgeable staff because they were cut from larger tablets (1/4 or 1/8).
Blinding (performance bias and detection bias) Outcome assessor	Low risk	Described as blind.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There were some inconsistencies in the figures; while 49 women seem to have been randomised there were 52 in the results tables.
Selective reporting (reporting bias)	Unclear risk	This was a pilot study and secondary measures for women and infants not specified in the methods text.
Other bias	Unclear risk	This was a pilot study with limited sample size. Authors state secondary outcomes analysed without stratification, but not what characteristic on which the sample would be stratified. The authors state the possibility of type II error due to inadequate sample size to evaluate neonatal outcomes.