Methods |
Trial conducted in Thailand, July 1999‐June 2001. |
Participants |
80 women undergoing second or third trimester (16 to 41 weeks' gestation) termination of pregnancy following both fetal demise or termination of a live fetus. Women were excluded if prior classical caesarean section or hypersensitive to prostaglandins. |
Interventions |
Women randomised to vaginal misoprostol (200 mcg at 12‐hourly intervals) or oral misoprostol (400 mcg at 4‐hourly intervals). |
Outcomes |
Vaginal birth not achieved within 24 hours; induction to birth interval; narcotic analgesia requirements; nausea; vomiting; diarrhoea; pyrexia. |
Notes |
Method of randomisation: random number table.
Allocation concealment: opaque sealed envelopes.
Blinding of participants, caregivers and outcome assessors: not stated. |
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 |
|