Bracken 2014*.

Methods	Double‐blind randomised trial. Randomised using a simple randomisation sequence generated by computer with blocks of 10. Randomisation was stratified by study site. Montefiore Medical Center, Stanford University, Stroger Hospital, Christiana Health System, the Huong Vuong Hospital in Ho Chi Minh City, Viet Nam; from December 2008 to December 2011
Participants	Women who sought medical care for possible fetal demise in pregnancies of between 14 and 28 weeks from December 2008 to December 2011. Confirmation of fetal demise and final gestational age were determined by ultrasound.
Interventions	Intervention: 100 mcg buccal misoprostol (n = 63). Study drug was administered at 6‐hourly intervals, for a maximum of 8 doses. Control: 200 mcg buccal misoprostol (n = 72). Study drug was administered at 6‐hourly intervals, for a maximum of 8 doses.
Outcomes	The primary outcome was the fetal‐placental delivery rate within 48 hours of misoprostol commencement without any additional intervention. Rates of success were compared across study arms.
Funding	This study was funded by a grant from the Office of Orphan Products Development of the United States Food and Drug Administration.
Declarations of interest	The authors declare no conflicts of interest.
Notes	This study included patients with gestational age > 24 weeks. We contacted the author, who could provided us with subgroup analysis for patients with gestational age < 24 weeks; therefore we were able to include this study in the review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The groups were created by Gynuity Health Projects using a simple randomization sequence generated by computer with blocks of 10. Randomization was stratified by study site". Comment: this is an adequate type of random sequence generation.
Allocation concealment (selection bias)	Low risk	Comment: the article states that research assistants created packages of medication but randomisation seems to be done by doctors, there probably was allocation concealment for the doctor randomising the patient.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: the flowchart shows that discontinuation was < 5%. All patients that were initially randomised were included in the analysis. Since there was no loss to follow‐up and discontinuation was very low, it is likely data outcome data were complete.
Selective reporting (reporting bias)	Unclear risk	Comment: the results section presents secondary outcome measures that were not mentioned in the methods section. Unclear whether these were all the outcomes measured, or if other variables were measured but not presented.
Other bias	Low risk	No other source of bias could be detected
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "A research assistant prepared numbered and sealed randomization packets before beginning enrolment. Each packet contained eight individually labelled dose envelopes. Each woman was administered a randomization envelope containing two tablets' (100 mcg misoprostol tablet + placebo resembling this tablet or 2 tablets of 100 mcg misoprostol)". Comment: probably the packets were handed out to the patients by other personnel than the research assistant preparing them; so there was probably blinding of both patients and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: the care taking physician was blinded for the intervention, and therefore also blinded during assessment of the outcome.