Schreiber 2018.
Methods | Parallel multi‐centre randomised controlled trial | |
Participants | Women with an anembryonic pregnancy, embryonic or fetal death with a gestational age between five and 12 weeks | |
Interventions | 200 mg of mifepristone, administered orally, followed by 800 mcg of misoprostol, administered vaginally (mifepristone‐pretreatment group) or 800 mcg of misoprostol alone, administered vaginally (misoprostol‐alone group) | |
Outcomes | Treatment success (defined as complete expulsion without the need of additional vacuum aspiration within 30 days after treatment) Secondary outcomes reported were rate of vacuum aspiration, blood transfusion, pelvic infection, side effects of medication such as nausea, diarrhoea, headache and fever. |
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Funding | Supported by the National Institute of Child Health and Human Development of the National Institutes of Health (Eunice Kennedy Shriver award number R01‐HD0719‐20 [to Dr. Schreiber] and Women’s Reproductive Health Research award number K12‐HD001265‐18 [to Dr. Sonalkar]). | |
Declarations of interest | Dr. Creinin reports receiving consulting fees from Danco Laboratories. No other potential conflict of interest relevant to this article was reported. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned in permuted blocks of two to eight, stratified according to trial site, with the use of Research Electronic Data Capture software". |
Allocation concealment (selection bias) | Low risk | Quote: "Participants were randomly assigned in permuted blocks of two to eight, stratified according to trial site, with the use of Research Electronic Data Capture software." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 2 women lost to follow‐up in intervention arm, 1 in the control arm. For 2 women, reasons for lost to follow‐up were not mentioned. In 1 women there was a suspicion of caesarean section scar pregnancy |
Selective reporting (reporting bias) | High risk | Quote: "assessments of quality of life, costs, and biomarkers that predict complete gestational sac expulsion were performed, but the data are not presented here". It is not mentioned if these outcomes are or will be presented elsewhere. |
Other bias | Low risk | No other bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no placebo was used, therefore blinding was not possible for both personnel and participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | At the initial follow‐up visit, an investigator who was unaware of the treatment‐group assignments assessed the outcome by means of endovaginal ultrasonography. |