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Medical management of first trimester miscarriage did not improve outcome, compared to expectant management
GY N ECO L OG Y
Medical management of first trimester miscarriage did not improve outcome, compared to expectant management Nielsen S, Hahlin M, Platz-Christensen J. Randomised trial comparing expectant with medical management for first trimester miscarriages. Br J Obstet Gynaecol 1999; 106: 804d807
OBJECTIVE To determine if medical management of inevitable miscarriage with mifepristone and misoprostol reduces the need for surgical evacuation, compared to expectant management. DESIGN Randomized controlled trial. Method of allocation was not described. The study had sufficient power to detect an absolute reduction of 22% in the need for surgical evacuation. SETTING University hospital in Sweden. SUBJECTS 122 women, mean age 32 years, with inevitable or incomplete miscarriage of a first trimester pregnancy, confirmed by vaginal ultrasonography showing retained products of conception 15–50 mm in diameter. The mean gestational age was 68 days and the mean serum human chorionic gonadotropin level was 9664 IU/L. 36% of women had an empty gestational sac, 38% had a sac with a fetus, and 26% had a complex mass with deformed sac. INTERVENTION 60 women were randomized to receive oral mifepristone 400 mg at the clinic and a single dose of oral misoprostol 400 g at home 48 hours later, and 62 women were managed expectantly. All women returned to the clinic 5 days later for vaginal ultrasonography and those with retained products '15 mm underwent surgical evacuation. MAIN OUTCOME MEASURES Empty uterus after 5 days, pain on a scale of 1–100, days of bleeding, convalescence time (days off work), satisfaction with management.
Commentary In 1995, Nielsen and Hahlin were the first to compare expectant management with surgical evacuation in a randomized trial in women with spontaneous first-trimester miscarriages. They convincingly demonstrated that complete evacuation rates and subsequent fertility did not differ between these treatments.1 The present study, performed by the same research group, is the first randomized trial comparing expectant management of miscarriage with medical therapy. Although this was a well-designed and executed study, the results would have been even more convincing if a placebo had been used in the control group. Its findings shed new light on several other reports comparing medical therapy with surgical evacuation in first-trimester miscarriages. These studies demonstrated medical management to be a feasible, cost-effective alternative for surgery.2,3 The present study, however, found no difference between expectant and medical management. Medical therapy, therefore, does not seem to offer any advantage. Because mifepristone and misoprostol cause gastrointestinal side-effects in approximately 50% of women and, obviously, increase costs, these drugs deserve no place in the management of spontaneous miscarriage.
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Evidence-based Obstetrics and Gynecology (2000) 2, 44 doi:10.1054/ebog.2000.0143, available online at http://www.idealibrary.com on
MAIN RESULTS After 5 days, 49/60 women (82%) in the medical management group had an empty uterine cavity, compared to 47/62 (76%) in the expectant management group (P"0.43, relative risk [RR] 1.1, 95% CI 0.9–1.3)*. The mean (SD) pain score for the 5 days following inclusion was 66 (26) with medical management and 62 (30) with expectant management (NS). The mean length of bleeding was 11 (3) days and 10 (3) days, respectively (NS). The mean convalescence time was longer for women who were managed medically: 3.7 (3.8) days compared to 1.9 (2.7) days (P"0.007). There was no significant difference between groups in mean degree of satisfaction with the management received. One woman in the medical management group and two women in the expectant management group developed pelvic inflammatory disease after surgical evacuation (P"1.0*). One woman in the expectant management group required emergency surgical evacuation because of severe bleeding 2 days after inclusion. CONCLUSION In women with an inevitable first trimester miscarriage, medical management did not improve outcome or reduce the requirement for surgical evacuation, compared to expectant management.
* Numbers calculated from data in article.
This conclusion brings us back to the old question of whether to intervene by means of surgical evacuation or to await the natural course of events in women with early pregnancy failure. Because these management options are so very different, the woman’s preferences should be allowed to play a key role: a typical situation where informeddshared decision making can be put into practice. Willem M. Ankum, MD, PhD University of Amsterdam, Amsterdam, The Netherlands
Literature cited 1. Nielsen S, Hahlin M. Expectant management of first-trimester spontaneous abortion. Lancet 1995; 345: 84d86 2. Hughes JRM, Hinshaw K, Henshaw R, Rispin R, Templeton AA. The costs of treating miscarriage: a comparison of medical and surgical management. Br J Obstet Gynaecol 1996; 103: 1217d1221 3. Chung TKH, Lee DTS, Cheung LP, Haines CJ, Chang AMZ. Spontaneous abortion: a randomized, controlled trial comparing surgical evacuation with conservative management using misoprostol. Fertil Steril 1999; 71: 1054d1059
^ 2000 Harcourt Publishers Ltd
Medical management of first trimester miscarriage did not improve outcome, compared to expectant management Nielsen S, Hahlin M, Platz-Christensen J. Randomised trial comparing expectant with medical management for first trimester miscarriages. Br J Obstet Gynaecol 1999; 106: 804d807
OBJECTIVE To determine if medical management of inevitable miscarriage with mifepristone and misoprostol reduces the need for surgical evacuation, compared to expectant management. DESIGN Randomized controlled trial. Method of allocation was not described. The study had sufficient power to detect an absolute reduction of 22% in the need for surgical evacuation. SETTING University hospital in Sweden. SUBJECTS 122 women, mean age 32 years, with inevitable or incomplete miscarriage of a first trimester pregnancy, confirmed by vaginal ultrasonography showing retained products of conception 15–50 mm in diameter. The mean gestational age was 68 days and the mean serum human chorionic gonadotropin level was 9664 IU/L. 36% of women had an empty gestational sac, 38% had a sac with a fetus, and 26% had a complex mass with deformed sac. INTERVENTION 60 women were randomized to receive oral mifepristone 400 mg at the clinic and a single dose of oral misoprostol 400 g at home 48 hours later, and 62 women were managed expectantly. All women returned to the clinic 5 days later for vaginal ultrasonography and those with retained products '15 mm underwent surgical evacuation. MAIN OUTCOME MEASURES Empty uterus after 5 days, pain on a scale of 1–100, days of bleeding, convalescence time (days off work), satisfaction with management.
Commentary In 1995, Nielsen and Hahlin were the first to compare expectant management with surgical evacuation in a randomized trial in women with spontaneous first-trimester miscarriages. They convincingly demonstrated that complete evacuation rates and subsequent fertility did not differ between these treatments.1 The present study, performed by the same research group, is the first randomized trial comparing expectant management of miscarriage with medical therapy. Although this was a well-designed and executed study, the results would have been even more convincing if a placebo had been used in the control group. Its findings shed new light on several other reports comparing medical therapy with surgical evacuation in first-trimester miscarriages. These studies demonstrated medical management to be a feasible, cost-effective alternative for surgery.2,3 The present study, however, found no difference between expectant and medical management. Medical therapy, therefore, does not seem to offer any advantage. Because mifepristone and misoprostol cause gastrointestinal side-effects in approximately 50% of women and, obviously, increase costs, these drugs deserve no place in the management of spontaneous miscarriage.
44
Evidence-based Obstetrics and Gynecology (2000) 2, 44 doi:10.1054/ebog.2000.0143, available online at http://www.idealibrary.com on
MAIN RESULTS After 5 days, 49/60 women (82%) in the medical management group had an empty uterine cavity, compared to 47/62 (76%) in the expectant management group (P"0.43, relative risk [RR] 1.1, 95% CI 0.9–1.3)*. The mean (SD) pain score for the 5 days following inclusion was 66 (26) with medical management and 62 (30) with expectant management (NS). The mean length of bleeding was 11 (3) days and 10 (3) days, respectively (NS). The mean convalescence time was longer for women who were managed medically: 3.7 (3.8) days compared to 1.9 (2.7) days (P"0.007). There was no significant difference between groups in mean degree of satisfaction with the management received. One woman in the medical management group and two women in the expectant management group developed pelvic inflammatory disease after surgical evacuation (P"1.0*). One woman in the expectant management group required emergency surgical evacuation because of severe bleeding 2 days after inclusion. CONCLUSION In women with an inevitable first trimester miscarriage, medical management did not improve outcome or reduce the requirement for surgical evacuation, compared to expectant management.
* Numbers calculated from data in article.
This conclusion brings us back to the old question of whether to intervene by means of surgical evacuation or to await the natural course of events in women with early pregnancy failure. Because these management options are so very different, the woman’s preferences should be allowed to play a key role: a typical situation where informeddshared decision making can be put into practice. Willem M. Ankum, MD, PhD University of Amsterdam, Amsterdam, The Netherlands
Literature cited 1. Nielsen S, Hahlin M. Expectant management of first-trimester spontaneous abortion. Lancet 1995; 345: 84d86 2. Hughes JRM, Hinshaw K, Henshaw R, Rispin R, Templeton AA. The costs of treating miscarriage: a comparison of medical and surgical management. Br J Obstet Gynaecol 1996; 103: 1217d1221 3. Chung TKH, Lee DTS, Cheung LP, Haines CJ, Chang AMZ. Spontaneous abortion: a randomized, controlled trial comparing surgical evacuation with conservative management using misoprostol. Fertil Steril 1999; 71: 1054d1059
^ 2000 Harcourt Publishers Ltd