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. |
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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. |