Methods |
Trial conducted in Sudan, February‐December 2002. |
Participants |
70 women undergoing second trimester termination of pregnancy following fetal demise. Women were excluded with prior uterine surgery, severe asthma, heart disease, parity greater than 7. |
Interventions |
Women randomised to vaginal misoprostol (100 mcg at 4‐hourly intervals) or oral misoprostol (100 mcg at 4‐hourly intervals). |
Outcomes |
Mean induction to birth interval; surgical evacuation of the uterus. |
Notes |
Method of randomisation: 'patients were randomised'.
Allocation concealment: not stated.
Blinding of participants, caregivers and outcome assessors: no. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Stated that "patients were randomised". |
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 |
|