| Methods |
Trial conducted in Australia, July 1996‐February 1997. |
| Participants |
150 women undergoing second trimester termination of pregnancy fetal anomalies or following intrauterine fetal death; trial stopped early after total 100 women randomised. |
| Interventions |
Women randomised to 1) vaginal misoprostol (200 mcg at 6‐hourly intervals); 2) vaginal gemeprost (1 mg at 3‐hourly intervals). |
| Outcomes |
Vaginal birth not achieved in 24 hours; median induction to birth interval; pain score > 5 (using VAS); analgesia requirements; surgical evacuation of the uterus; nausea; vomiting; diarrhoea; pyrexia. |
| Notes |
Method of randomisation: random number table.
Allocation concealment: opaque sealed envelopes.
Blinding of participants (yes), caregivers (no) and outcome assessors (yes). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table. |
| Allocation concealment (selection bias) |
Low risk |
Opaque sealed envelopes. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of participants and outcome assessor. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Unclear risk |
Trial stopped early. |
