Demetroulis 2001.
Methods | Randomisation by opening sealed opaque envelope containing computer‐generated allocation code number. No attempt at masking given the manifest differences between medical and surgical interventions. Newham General Hospital; no information on study duration. |
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Participants | 80 women with incomplete miscarriage or anembryonic pregnancy or missed miscarriage < 13 weeks, diagnosed by ultrasound. The data in this review are derived only from the subgroup with non‐viable pregnancies (n = 50) and not those with incomplete miscarriages. Women were reviewed 8‐10 hours after medical treatment; if they had empty uteruses on ultrasound examination they were discharged home; if not, surgical evacuation was arranged. | |
Interventions | Vaginal misoprostol 800 mcg once only (n = 26) vs surgical evacuation of the uterus (n = 24). | |
Outcomes | Need for surgical evacuation, symptoms including pain and bleeding, 'satisfaction'. | |
Funding | No information on funding. | |
Declarations of interest | No information on conflicts of interest. | |
Notes | Authors contacted for information on outcomes according to indication for treatment. Only usable data currently available are on incidence of surgical evacuation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: computer‐generated numbers. |
Allocation concealment (selection bias) | Low risk | Comment: use of sealed opaque envelopes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data, it seems that all patients completed the study. |
Selective reporting (reporting bias) | Low risk | Comment: no signs of selective reporting. 94 patients were counselled, 14 declined study participation and chose surgical evacuation. All outcome measures mentioned in the methods section were reported in the results section. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "No attempt was made to conceal the intervention assignment schedule from the patients or clinicians as the treatment methods for the study and control were obviously different (...) No attempt was made to mask the intervention as the study compared a medical treatment with a surgical procedure". Comment: this might have influenced (perception of) outcome. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not performed. Quote: "No attempt was made to mask the intervention as the study compared a medical treatment with a surgical procedure". |