Methods | RCT with randomisation of individual women. Sequentially numbered opaque envelopes, using pseudo-random number generator | |
Participants | Inclusion criteria • Women with signs of incomplete miscarriage. • Diagnosis confirmed by ultrasound. • 1st trimester; good general health; no allergy to misoprostol; good access to emergency facilities. • N = 169 women. Exclusion criteria • None specified. |
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Interventions | Intervention: oral misoprostol - 600 ug, single dose (N = 86). Comparison: oral misoprostol - 1200 ug, 2 doses, 4 hours apart (N = 83) |
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Outcomes | Complete miscarriage at 48 hours; surgical evacuation; side effects and acceptability • Assessed by ultrasound at 48 hours. • If miscarriage not complete at 48 hours, women were given the option to wait additional 5 days (1 week from misoprostol administration) to see if miscarriage would be complete without further intervention. If miscarriage not complete after 1 week or if woman refused extension, then she underwent surgical evacuation according to standard practice. |
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Notes | 1. Setting: 2 teaching hospitals in Bangkok, Thailand. 2. Additional outcomes assessed but not pre-specified in the review: bleeding (heavy, normal, spotting); pain; fever; medically necessary interventions; satisfied or very satisfied with treatment. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Pseudo-random number generator in SSPS 9.0.” |
Allocation concealment (selection bias) | Low risk | Women given the next “…sequentially numbered opaque envelope; the number in the envelope became her study identification number” |
Blinding (performance bias and detection bias) All outcomes |
High risk | “Neither the provider nor the woman was blinded to the treatment regimes.” |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | 2 women in single-dose group and 1 woman in double-dose group were lost to follow up. 1.8% of total, so no real impact. |
Selective reporting (reporting bias) | Unclear risk | Appears to be free of selective reporting bias but we did not assess the trial protocol |
Other bias | Low risk | Appears to be free of other reporting bias. |