Methods |
Trial conducted in South Africa. |
Participants |
38 women in second or third trimester of pregnancy with intrauterine fetal death. Women were excluded with fetal malpresentation, macrosomia, uterine scar, contraindication to prostaglandin medication, hepatic failure or renal failure. |
Interventions |
Women were randomised to 1) oral misoprostol (200 mcg at 6‐hourly intervals) or 2) vaginal misoprostol (200 mcg at 6‐hourly intervals). |
Outcomes |
Induction to delivery interval; serious maternal morbidity; maternal side effects. |
Notes |
Method of randomisation: "Envelope picked at random".
Allocation concealment: 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) |
Unclear risk |
"Envelope picked at random". |
Allocation concealment (selection bias) |
Unclear risk |
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 |
|