Methods |
Trial conducted in Finland, June 1995‐May 1996. |
Participants |
81 women undergoing second trimester termination of pregnancy for fetal anomalies or following intrauterine fetal death. Women excluded if uterine scar; contractions; bleeding vaginally. |
Interventions |
Women randomised to vaginal misoprostol (100 mcg at 6‐hourly intervals) or vaginal misoprostol (200 mcg at 12‐hourly intervals), or gemeprost (1 mg at 3‐hourly intervals). |
Outcomes |
Mean induction to birth interval; analgesia requirements; surgical evacuation of the uterus; vomiting; diarrhoea. |
Notes |
Method of randomisation: random number table.
Allocation concealment: sealed opaque 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 |
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 |
|