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. 2019 Jun 17;2019(6):CD002253. doi: 10.1002/14651858.CD002253.pub4

Bagratee 2004.

Methods Computer‐generated random allocation of study number. Numbered envelopes containing misoprostol or placebo.
All women presenting to the Early Pregnancy Assessment Unit (EPAU) at St Mary's Hospital, London, UK, from August 2001 to March 2002.
Participants 104 women who attended Early Pregnancy Unit, St Mary's Hospital, with incomplete miscarriage or early pregnancy failure < 13 weeks.
Interventions 600 mcg misoprostol (n = 52) or placebo [expectant management] (n = 52). Second dose next day unless complete miscarriage had occurred in meantime. Review day 7 and surgical evacuation if miscarriage not complete. Further review at day 14.
Outcomes Primary: complete miscarriage without need for ERPC by day 7. Secondary outcomes: clinical, side effects, satisfaction and future choices.
Funding No information on funding.
Declarations of interest No information on conflicts of interest.
Notes Primary outcome reported for both non‐viable pregnancies and incomplete miscarriages, but not for secondary outcomes. These will be added if authors can provide data separately for non‐viable pregnancies and incomplete miscarriages.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Computer‐based allocation", allocation "according to the random schedule".
Allocation concealment (selection bias) Low risk Quote: "Three misoprostol or placebo tablets were placed in each of two small envelopes and sealed. These small envelopes were then placed in consecutively numbered larger envelopes according to the random schedule and sealed by staff not involved in the study".
Comment: adequate allocation concealment.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "The 104 women randomized to the trial attended the scheduled visits as per protocol and completed the trial".
Comment: no signs of missing data.
Selective reporting (reporting bias) Low risk Comment: all outcomes mentioned in the methods section were presented in the results section, no signs of selective reporting.
Other bias Low risk No other source of bias could be detected
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Three misoprostol or placebo tablets were placed in each of two small envelopes and sealed. These small envelopes were then placed in consecutively numbered larger envelopes according to the random schedule and sealed by staff not involved in the study".
Comment: this means both patients as well as the doctor randomising the patients were unaware of the type of treatment.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: patients and doctors randomising the patients were blinded for treatment allocation (see blinding of participants and personnel above), assuming the doctor assessing the outcome was the same as the 1 randomising the patients, there was sufficient blinding of outcome assessment.