Methods |
Trial conducted in Sudan, February‐November 2006. |
Participants |
150 women with intrauterine fetal death in the second trimester of pregnancy. Women with prior uterine surgery, asthma, heart disease or more than 7 previous pregnancies were excluded from the study. |
Interventions |
Women were randomised to 1) oral misoprostol (100 mcg at 4‐hourly intervals); 2) vaginal misoprostol (100 mcg at 4‐hourly intervals); or 3) sublingual misoprostol (100 mcg at 4‐hourly intervals). |
Outcomes |
Vaginal birth not achieved in 24 hours; induction to delivery interval. |
Notes |
Method of randomisation: stated to be an "open randomised controlled clinical trial".
Allocation concealment: not stated.
Blinding of participants, caregivers, outcome assessors: no. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Stated to be an "open randomised controlled clinical trial". |
Allocation concealment (selection bias) |
Unclear risk |
Not stated. |
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 |
|