| Methods |
Trial conducted in Thailand, December 2000‐December 2003. |
| Participants |
276 women undergoing second trimester termination for fetal anomalies or following intrauterine fetal death. Women were excluded with cardiac disease, severe asthma, hepatic or renal disease, or prelabour ruptured membranes. |
| Interventions |
Women randomised to vaginal misoprostol (600 mcg at 6‐hourly intervals) or vaginal misoprostol (600 mcg at 12‐hourly intervals). |
| Outcomes |
Vaginal birth not achieved within 24 hours; induction to birth interval (median); analgesia requirements; blood loss greater than 500 mL; need for blood transfusion; surgical evacuation of the uterus; nausea; vomiting; diarrhoea; fever. |
| Notes |
Method of randomisation: random number table.
Allocation concealment: sealed opaque envelopes.
Blinding of participants, caregivers or 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 |
Sealed opaque 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 |
|
