Methods | RCT with randomisation of individual women. | |
Participants | Inclusion criteria
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Interventions | Intervention: oral mifepristone + vaginal misoprostol.
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Outcomes | Complete abortion rate; bleeding; pain; satisfaction; complications including infection (clinical signs or elevated infection parameters in lab tests) treated with oral or IV antibiotics; continuous and heavy bleeding; blood transfusions; curettage for any reason; intense pain requiring admission | |
Notes | Setting: Oulu University Hospital, Finland. The 19 women with incomplete spontaneous miscarriage were part of a larger study of 98 women who had had various forms of miscarriage (incomplete spontaneous miscarriage; anembryonic pregnancy; missed miscarriage). Separate data were available from the authors for the women with incomplete spontaneous miscarriage. Of the 19 women, 16 were < 13 weeks’ gestation and 3 were between 13 and 23 weeks’ gestation. This information is held at the Cochrane Pregnancy and Childbirth Group Office |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “…computer randomised program with the block length of 6.” |
Allocation concealment (selection bias) | Low risk | “An independent consult performed the randomisation and assigned the randomisation list to a secretary, who made the numbered opaque envelopes for the study. …Allocation concealment was used to confirm that neither the clinician nor the patient knew the type of treatment in advance… After informed consent the next numbered envelope was opened to define the type of treatment of each patient.” |
Blinding (performance bias and detection bias) All outcomes |
High risk | Cannot blind women nor clinicians to the treatment because this study compared medical versus surgical treatment |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Authors randomised 98 women (19 with ICM and 79 with IUFD) with 49 in each group. Of these, they reported on 48 in medical and 47 in surgical groups because 1 woman in the medical management group had an ERPC and in the surgical group one woman had an emergency ERPC and one had a spontaneous complete miscarriage. Of these women only 19 had incomplete miscarriage (the remainder had intrauterine deaths) and of these all appear to be accounted for in the analysis |
Selective reporting (reporting bias) | Unclear risk | We did not assess the protocol, and additionally the authors did not report on bleeding; blood transfusions’ |
Other bias | Low risk | No apparent additional biases apparent. |