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. Author manuscript; available in PMC: 2014 Jun 3.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007223. doi: 10.1002/14651858.CD007223.pub2
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.
Interventions Intervention: vaginal prostaglandin.
• Prostaglandin E1 analogue (gemeprost).
• N = 17.
Comparison: surgical management.
• Curettage.
• N = 17.
Outcomes Duration of vaginal bleeding; pain; discomfort experienced; sick days and days of absence
• Assessed at 5-8 days using transvaginal ultrasound.
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.
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