| Methods |
Randomised controlled trial, single university affiliated tertiary medical centre, between August 2015 and June 2016 |
| Participants |
Women diagnosed with early pregnancy loss in the gynaecologic emergency room, either anembryonic gestation or embryonic death, were eligible for inclusion if pregnancy size by TVS was up to 12 weeks’ gestation |
| Interventions |
800 mcg vaginal misoprostol + 800 mcg vaginal misoprostol on day 4 (n = 84); 800 mcg vaginal misoprostol (n = 87) |
| Outcomes |
The primary outcome was treatment success, defined as no need for surgical intervention up to Day 8. This included emergent and elective surgical interventions. Secondary outcomes were adverse effects, pain level, OTC analgesics use, treatment acceptability and the need for late intervention as reported by the participants by telephone on day 45. |
| Funding |
The authors did not receive funding for this study |
| Declarations of interest |
The authors declare no conflict of interest. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "subjects were randomly assigned to either a single‐dose protocol or a repeat‐dose protocol in a 1:1 ratio. A blocked randomization scheme was created using a computer generated list of random numbers. Each block consisted of 30 participants." |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Treatment allocation was concealed by placing assignments in sequentially numbered opaque envelopes" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: flow chart displays all outcome data available. Missing data are explained. |
| Selective reporting (reporting bias) |
Low risk |
Comment: no signs of selective reporting, all outcomes described are presented in results |
| Other bias |
Low risk |
No other source of bias could be detected |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Comment: due to the nature of the intervention blinding would be difficult |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Comment: blinding of outcome assessor is not described |
