Methods |
Trial conducted in Turkey, January‐December 2003. |
Participants |
153 women at 13 to 20 weeks' gestation presenting for termination with either fetal anomaly or intrauterine fetal death. Women with an allergy to misoprostol were excluded from the study. |
Interventions |
Women randomised to 1) oral misoprostol (100 mcg at 2 hourly intervals); 2) vaginal misoprostol (200 mcg at 4 hourly intervals); or 3) sublingual misoprostol (100 mcg at 2 hourly intervals). |
Outcomes |
Vaginal birth not achieved in 24 hours; induction to delivery interval; analgesic requirements; side effects. |
Notes |
Method of randomisation: computer generated sequence.
Allocation concealment: unclear (possibly sealed opaque envelopes).
Blinding: participants, caregivers and outcome assessor ‐ no. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated sequence. |
Allocation concealment (selection bias) |
Unclear risk |
Unclear ‐ possible use of 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 |
Unclear risk |
Unable to assess. |