| Methods |
Trial conducted in Canada, September 1998‐November 2001. |
| Participants |
114 women undergoing second trimester termination of pregnancy following both fetal demise or termination of a live fetus. Women were excluded if hypersensitive to prostaglandins or had limited English. |
| Interventions |
Women randomised to vaginal misoprostol (400 mcg at 4‐hourly intervals) or oral misoprostol (200 mcg at hourly intervals for 3 hours then 400 mcg at 4‐hourly intervals). |
| Outcomes |
Vaginal birth not achieved within 24 hours; induction to birth interval; mean blood loss; surgical evacuation of the uterus; serious maternal morbidity; pyrexia. |
| Notes |
Method of randomisation: 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 |
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 |
|
