| Methods |
Trial conducted in the Netherlands, May 2003‐August 2004. |
| Participants |
16 women with single fetus in second trimester of pregnancy (14 to 24 weeks' gestation) where termination for fetal anomalies. Women with uterine scar or contraindication to the use of misoprostol or mifepristone were excluded. |
| Interventions |
Women were randomised to 1) mifepristone followed by vaginal misoprostol (200 mcg at 3‐hourly intervals) or 2) vaginal hydrophilic rods (Dilapan) and infusion of prostaglandin E2 (sulprostone). |
| Outcomes |
Vaginal birth not achieved in 24 hours; induction to delivery interval. |
| Notes |
Method of randomisation: random number table.
Allocation concealment: opaque sealed envelopes.
Blinding of participants, caregivers, outcome assessors: not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
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 |
|
