Philadelphia—Medical management of early pregnancy loss has been promoted as an alternative to uterine aspiration, but standard medical treatment with misoprostol commonly results in treatment failure, according to a new study.
The report in the New England Journal of Medicine describes research comparing the safety and effectiveness of pretreatment with mifepristone followed by treatment with misoprostol versus misoprostol use alone for the management of early pregnancy loss.
For the trial, University of Pennsylvania–led researchers randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed into two groups. In one, participants received pretreatment with 200 mg of mifepristone, administered orally, followed by 800 micrograms of misoprostol, administered vaginally—the mifepristone-pretreatment group. In the other, the women received 800 micrograms of misoprostol alone, administered vaginally—the misoprostol-alone group.
One to 4 days after misoprostol use, participants returned for evaluation, including ultrasound examination, by an investigator who was unaware of the treatment-group assignments.
Expectant management, a second dose of misoprostol, or uterine aspiration were offered to women in whom the gestational sac had not been expelled.
The study team followed all participants for 30 days after randomization to identify the primary outcome: gestational sac expulsion with one dose of misoprostol by the first follow-up visit, as well as no additional intervention within 30 days after treatment.
Results indicate that complete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8-89.3) in the mifepristone-pretreatment group versus 100 of 149 women (67.1%; 95% CI, 59.0-74.6) in the misoprostol-alone group (relative risk, 1.25; 95% CI, 1.09-1.43).
One result, researchers report, was that uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21-0.68).
Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P = .31), however. Pelvic infection rates didn’t differ, with diagnosis in 1.3% of the women in each group.
“Pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone,” study authors conclude.
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The report in the New England Journal of Medicine describes research comparing the safety and effectiveness of pretreatment with mifepristone followed by treatment with misoprostol versus misoprostol use alone for the management of early pregnancy loss.
For the trial, University of Pennsylvania–led researchers randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed into two groups. In one, participants received pretreatment with 200 mg of mifepristone, administered orally, followed by 800 micrograms of misoprostol, administered vaginally—the mifepristone-pretreatment group. In the other, the women received 800 micrograms of misoprostol alone, administered vaginally—the misoprostol-alone group.
One to 4 days after misoprostol use, participants returned for evaluation, including ultrasound examination, by an investigator who was unaware of the treatment-group assignments.
Expectant management, a second dose of misoprostol, or uterine aspiration were offered to women in whom the gestational sac had not been expelled.
The study team followed all participants for 30 days after randomization to identify the primary outcome: gestational sac expulsion with one dose of misoprostol by the first follow-up visit, as well as no additional intervention within 30 days after treatment.
Results indicate that complete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8-89.3) in the mifepristone-pretreatment group versus 100 of 149 women (67.1%; 95% CI, 59.0-74.6) in the misoprostol-alone group (relative risk, 1.25; 95% CI, 1.09-1.43).
One result, researchers report, was that uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21-0.68).
Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P = .31), however. Pelvic infection rates didn’t differ, with diagnosis in 1.3% of the women in each group.
“Pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone,” study authors conclude.
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