| Methods |
Trial conducted in United States of America. |
| Participants |
30 women undergoing termination of pregnancy following both fetal demise or termination of a live fetus (gestational age 16 to 24 weeks). Women excluded if severe pre‐eclampsia, cervical dilatation greater than 2 cm or sensitivity to prostaglandins. |
| Interventions |
Women randomised to vaginal misoprostol (200 mcg at 12‐hourly intervals) or vaginal prostaglandin E2 (40 mg) and concentrated oxytocin infusion. |
| Outcomes |
Vaginal birth not achieved within 24 hours; induction to birth interval; surgical evacuation of the uterus. |
| Notes |
Method of randomisation: computer‐generated random number table.
Allocation concealment: opaque 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) |
Low risk |
Computer‐generated random number table. |
| Allocation concealment (selection bias) |
Low risk |
Opaque 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 |
|
