| Methods |
Trial conducted in United States of America; gestational age 12 to 22 weeks. |
| Participants |
100 women undergoing termination of pregnancy following both fetal demise or termination of a live fetus. Women excluded if prior uterine incision, maternal infection, cervical dilatation, uterine bleeding, or maternal pulmonary, hepatic, renal or cardiovascular disease. |
| Interventions |
Women randomised to vaginal misoprostol (200 mcg at 6‐hourly intervals) or vaginal misoprostol (200 mcg at 12‐hourly intervals). |
| Outcomes |
Vaginal birth not achieved within 24 hours; induction to birth interval; narcotic analgesia requirements; need for blood transfusion; surgical evacuation of the uterus; vomiting; diarrhoea; pyrexia. |
| Notes |
Method of randomisation: random number table.
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) |
Low risk |
Random number table. |
| 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 |
|
