Methods | RCT with randomisation of individual women. | |
Participants | Inclusion criteria • Women with miscarriage up to 12 weeks’ gestation. • Transvaginal ultrasound used. • Only those women (N = 34) with endometrial thickness > 10 cm were randomised, the remaining women (N = 27) had endometrial thickness < 10 cm an were managed by expectancy. • N = 61 women. Exclusion criteria • Women with intrauterine device in situ, missed abortion flow/blighted ovum, extrauterine pregnancy or mola. |
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Interventions | Intervention: vaginal prostaglandin. • Prostaglandin E1 analogue (gemeprost). • N = 17. Comparison: surgical management. • Curettage. • N = 17. |
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Outcomes | Duration of vaginal bleeding; pain; discomfort experienced; sick days and days of absence • Assessed at 5-8 days using transvaginal ultrasound. |
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Notes | 1. Setting: district hospital in Glostrup, Copenhagen, Denmark. 2. Paper written in Danish, with English abstract. Paper was translated. 3. Additional outcomes assessed but not pre-specified in the review: bleeding; pain; days of sick leave; women’s dissatisfaction. The participants were divided into 2 groups: • Group 1 (27) with an endometrial thickness of less than 10mm and • Group 2 (34) with an endometrial thickness greater than 10mm. Group 1 was managed by expectancy and Group 2 was further divided into 2 groups again at random: • Group 2 A (17) which was given Prostaglandin E1 analogue gemeprost (1 mg). • Group 2 B (17) which underwent curettage. This review looked only at group 2A versus 2B. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “The participating women were chosen at random by the drawing of lots into 2 parallel groups.” |
Allocation concealment (selection bias) | Unclear risk | “The participating women were chosen at random by the drawing of lots into 2 parallel groups.” No further information |
Blinding (performance bias and detection bias) All outcomes |
High risk | Not possible to blind women nor clinicians. No mention of whether assessors were blinded or not |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | 4 women did not complete the trial period. 2 from Gemeprost group and 0 from curettage group (2 from expectant group). 6% loss but both from the medical management group |
Selective reporting (reporting bias) | Unclear risk | There is no mention of the outcomes to be measured although there was a questionnaire sent to women and this may well have been designed before the study began. Also, we did not assess the trial protocol |
Other bias | Low risk | “The patients in all groups were comparable regarding age, previous births and previous spontaneous or instigated abortions.” There was no other information which would suggest other biases |