| Methods |
Double‐blind randomised study. Medication kept in opaque packets. Unclear whether the randomisation envelopes were sequentially numbered or whether a envelope was randomly picked from a selection of 4 ("randomised in blocks of 4"). |
| Participants |
146 women at term with singleton pregnancies, intact membranes and a BS < 7. Women with an estimated fetal weight of > 4 kg, previous CS or parity > 5 excluded. |
| Interventions |
A single dose of 50 mcg oral misoprostol and vitamin B6 placebo vaginally or 25 mcg vaginal misoprostol with vitamin B6 oral placebo. The single dose of either was followed by iv oxytocin 6 hours later. |
| Outcomes |
Labour and delivery outcomes.
Neonatal outcomes. |
| Notes |
No exclusions. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
|
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
|
