| Methods |
Trial conducted in Australia, March 1998‐February 1999. |
| Participants |
150 women undergoing second or third trimester termination of pregnancy for fetal anomaly or after intrauterine fetal death. |
| Interventions |
Women randomised to 1) vaginal misoprostol (200 mcg at 6‐hourly intervals); 2) vaginal misoprostol (400 mcg at 6‐hourly intervals); or 3) vaginal misoprostol loading dose (600 mcg) followed by vaginal misoprostol (200 mcg at 6‐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. |
| Notes |
Method of randomisation: 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 |
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 |
|
