Randomised clinical trial of medical evacuation and surgical curettage for incomplete miscarriage

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Abstract
Patients, methods, and results We conducted a randomised clinical trial of 50 consecutive patients fulfilling the following eligibility criteria: history of amenorrhoea followed by abdominal cramping and vaginal bleeding; uterine size 90 g/l after resuscitation; and no contraindication to prostaglandin treatment. Medical management consisted of a single dose of misoprostol 400 μg orally and was considered to be successful if bleeding had reverted to a blood stained discharge, pain had subsided, the uterus was smaller, and the cervical opening had closed on repeat pelvic examination 12 hours after misoprostol administration. Pelvic ultrasonography was performed when uncertainty existed about the completeness of the abortion. Surgical curettages were performed twice a day. A hundred opaque sealed envelopes were randomised by means of computer generated random numbers. Even numbers were assigned to misoprostol and odd numbers to surgical evacuation. The study was approved by the hospital ethics committee. Informed consent was obtained in all cases. No case was excluded because of excessive bleeding. The protocol included an interim analysis of 50 cases, and after analysis the study was stopped. This resulted in differences in size of the two groups. The χ2, Mann-Whitney U, and Wilcoxon matched pairs tests were used for statistical analysis where appropriate. The table summarises demographic data and findings. The two groups were comparable in terms of the entry criteria. Only 3 (13%) of the women receiving misoprostol had a successful evacuation compared with 26 (97%) of the women in the surgical group (P<0.00001). In the misoprostol group there was a significant fall in haemoglobin concentration after treatment (P=0.04), whereas no difference was found in the surgical group (P=0.76). View this table: In this window In a new window Comparison of medical evacuation and surgical curettage for uncomplicated incomplete miscarriage. Values are medians (ranges) unless stated otherwise