OBJECTIVE: To compare the efficacy of two different medical treatment regimens: mifepristone 600 mg orally + misoprostol 0.4 mg vaginally (Mf + Ms) or misoprostol 0.4 mg vaginally (Ms) with conventional surgical evacuation (SE) in women with missed abortion. MATERIALS AND METHODS: Prospective crossover study with alternating regimens every 4 months. The three university clinics of Obstetrics and Gynecology in Gentofte, Herlev and Glostrup of Copenhagen County. During the period October 1999 to October 2000, 176 women with missed abortion accepted to participate in the study. RESULTS: The proportion of women who needed surgical evacuation after medical treatment, number of women who needed re-evacuation after primary surgical evacuation, duration of vaginal bleeding, treated infections, need of analgesics, and the subjective experiences from the participating women. Fifty-four, 73 and 49 patients were randomized to Mf + Ms, Ms and SE, respectively. Within 1 week, complete expulsion occurred in 40 (74%), 52 (71%), 47 (96%) of the three arms, respectively. Duration of bleeding was 6.9, 7.1 and 2.5 days in the three arms, respectively (p < 0.01). Women with an initial plasma chorionic gonadotrophine (p-hCG) between 2000 and 20 000 IU/l and a gestational age less than 75 days had a significantly better response to the medical treatment than those not fulfilling these two criteria. Initial p-progesterone did not correlate with success of medical treatment. MAIN OUTCOME MEASURES: Proportion of women who needed surgical evacuation after medical treatment, and the number of women who needed re-evacuation after primary surgical evacuation, duration of vaginal bleeding, treated infections, the need of analgesics, and subjective experiences from participating women. CONCLUSION:Vaginal misoprostol 0.4-0.6 mg is effective in most patients with missed abortion. Pre-treatment with the antiprogesterone mifepristone does not increase the success rate. The selection of women with missed abortion for medical treatment based on gestational age and initial p-hCG level may increase the success of medical treatment significantly.
RCT Entities:
OBJECTIVE: To compare the efficacy of two different medical treatment regimens: mifepristone 600 mg orally + misoprostol 0.4 mg vaginally (Mf + Ms) or misoprostol 0.4 mg vaginally (Ms) with conventional surgical evacuation (SE) in women with missed abortion. MATERIALS AND METHODS: Prospective crossover study with alternating regimens every 4 months. The three university clinics of Obstetrics and Gynecology in Gentofte, Herlev and Glostrup of Copenhagen County. During the period October 1999 to October 2000, 176 women with missed abortion accepted to participate in the study. RESULTS: The proportion of women who needed surgical evacuation after medical treatment, number of women who needed re-evacuation after primary surgical evacuation, duration of vaginal bleeding, treated infections, need of analgesics, and the subjective experiences from the participating women. Fifty-four, 73 and 49 patients were randomized to Mf + Ms, Ms and SE, respectively. Within 1 week, complete expulsion occurred in 40 (74%), 52 (71%), 47 (96%) of the three arms, respectively. Duration of bleeding was 6.9, 7.1 and 2.5 days in the three arms, respectively (p < 0.01). Women with an initial plasma chorionic gonadotrophine (p-hCG) between 2000 and 20 000 IU/l and a gestational age less than 75 days had a significantly better response to the medical treatment than those not fulfilling these two criteria. Initial p-progesterone did not correlate with success of medical treatment. MAIN OUTCOME MEASURES: Proportion of women who needed surgical evacuation after medical treatment, and the number of women who needed re-evacuation after primary surgical evacuation, duration of vaginal bleeding, treated infections, the need of analgesics, and subjective experiences from participating women. CONCLUSION: Vaginal misoprostol 0.4-0.6 mg is effective in most patients with missed abortion. Pre-treatment with the antiprogesterone mifepristone does not increase the success rate. The selection of women with missed abortion for medical treatment based on gestational age and initial p-hCG level may increase the success of medical treatment significantly.
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