Methods | RCT with randomisation of individual women. | |
Participants | Inclusion criteria • Women with incomplete miscarriage. • Women of 18 years or older, living or working within 1 h of the study hospital, no known contraindication to misoprostol and general good health. • N = 300 women. Exclusion criteria • None specified. |
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Interventions | Intervention: oral misoprostol - 600 ug. N = 150. Comparison: oral misoprostol - 1200 ug (2 × 600 ug, 4 hours apart). N = 150 |
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Outcomes | Complete evacuation without recourse to surgery; women’s satisfaction and acceptability | |
Notes | 1. Setting: large tertiary facility in Ho Chi Minh City in Southern Vietnam. 2. Mean gestational age was 8.1 weeks, so we consider all to be less than 13 weeks’ gestation, this was confirmed by personal communication with co-author J Blum but we have emailed the first author to confirm as suggested. 3. Additional outcomes assessed but not pre-specified in the review: bleeding; pain/cramps; fever/chills; tolerability; would choose again; would recommend to a friend. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “…computer generated random sequence…” |
Allocation concealment (selection bias) | Unclear risk | “…opening the next study envelope…” |
Blinding (performance bias and detection bias) All outcomes |
High risk | Although comparing drug doses, because the comparator group were given second dose 4 hours later, this was not blinded from participants not caregivers |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | 5 women lost to follow up: 1/150 for single dose and 4/150 for repeat dose. Authors made every effort to contact women, both by phone and visits but unsuccessfully for these 5 women. There were no exclusion reported although some outcomes were only available on 145 of the women in the double dose group rather than 146. The analysis was not by intention to treat because of the lost data, but we considered the loss was small enough for there to be no important bias |
Selective reporting (reporting bias) | Unclear risk | Seem to have reported all pre-specified outcomes, but we did not access the trial protocol |
Other bias | Low risk | There was nothing to suggest any other risk of bias. |