| Methods |
Trial conducted in United States, April 1999‐May 2002. |
| Participants |
100 women undergoing second trimester termination of pregnancy for fetal anomalies or following intrauterine fetal death. Women excluded if hypersensitivity to prostaglandins, clinical chorioamnionitis, prior caesarean section or uterine surgery, active labour, placenta praevia. |
| Interventions |
Women randomised to vaginal misoprostol (600 mcg followed by 400 mcg at 4‐hourly intervals) or vaginal PGE2 and oxytocin. |
| Outcomes |
Vaginal birth not achieved within 24 hours; mean induction to delivery interval; analgesia requirements; blood loss greater than 500 mL; surgical evacuation of the uterus; nausea or vomiting; diarrhoea; pyrexia. |
| Notes |
Method of randomisation: computer‐generated random number table.
Allocation concealment: opaque sealed envelopes.
Blinding of participants, caregivers and outcome assessors: no. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number table. |
| Allocation concealment (selection bias) |
Low risk |
Opaque sealed envelopes. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not stated. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Low risk |
|
