Methods |
Non‐blinded randomised comparative trial. Computer‐generated sequence in sealed opaque envelopes. |
Participants |
100 women at term with medical or obstetric indications for induction of labour. Exclusion criteria: previous caesarean section, twins, contraindications to prostaglandins. Inclusion criteria: term, singleton, cephalic, unfavourable cervix, reassuring CTG. |
Interventions |
50 µg misoprostol sublingually vs orally every 4 hrs to maximum of 5 doses. |
Outcomes |
Primary: number of women who delivered vaginally within 24 hrs of induction. Secondary: need for oxytocin, mode of delivery, caesarean section for fetal distress, uterine hyperstimulation, neonatal outcomes acceptability to the women. |
Notes |
Aberdeen Maternity Hospital, June to September 2000. No exclusions after recruitment. No protocol violations. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |