| Methods |
Trial conducted in United States of America; gestational age 12 to 22 weeks. |
| Participants |
68 women undergoing termination of pregnancy following both fetal demise or termination of a live fetus. Women excluded if uterine incision, cervical dilatation, maternal infection, maternal pulmonary, renal, hepatic or cardiovascular disease. |
| Interventions |
Women randomised to vaginal misoprostol (200 mcg at 12‐hourly intervals) or vaginal misoprostol (200 mcg at 12‐hourly intervals) and laminarae. |
| Outcomes |
Vaginal birth not achieved within 24 hours; blood loss; need for blood transfusion; vomiting; diarrhoea; pyrexia. |
| Notes |
Method of randomisation: women were "randomised".
Allocation concealment: not stated.
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 |
Stated that "women were randomised". |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated. |
| 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 |
|
