| Methods |
Trial conducted United States of America. |
| Participants |
51 women undergoing termination of pregnancy with a live fetus with fetal anomaly (gestational age 17 to 24 weeks). Women excluded if fetal death, oligohydramnios, or contraindication to the use of prostaglandins. |
| Interventions |
Women randomised to vaginal misoprostol (200 mcg at 12‐hourly intervals) with laminarae or intra‐amniotic prostaglandin F2 alpha and laminarae. |
| Outcomes |
Vaginal birth not achieved within 24 hours; induction to birth interval; mean blood loss; surgical evacuation of the uterus; nausea; vomiting; diarrhoea; pyrexia. |
| 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 |
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 |
Low risk |
|
