Elsevier

Obstetrics & Gynecology

Volume 98, Issue 3, September 2001, Pages 434-439
Obstetrics & Gynecology

Original research
Mifepristone 100 mg in abortion regimens

https://doi.org/10.1016/S0029-7844(01)01462-4Get rights and content

Abstract

OBJECTIVE:

To examine the clinical efficacy of mifepristone 100 mg followed 2 days later by misoprostol 400 μg orally or 800 μg vaginally in women at up to 49 days’ gestation.

METHODS:

Eighty participants received mifepristone 100 mg and then were randomized to misoprostol, administered 48 hours later, at a dose of 400 μg orally (group 1) or 800 μg vaginally (group 2). Women returned for follow-up evaluations 24 ± 1 hour after using the misoprostol and then 2–3 weeks later. If abortion still had not occurred and the pregnancy was nonviable, the subject returned again after an additional 3 weeks.

RESULTS:

Twenty-four hours after receiving misoprostol, 34 (85%; 95% confidence interval [CI] 71%, 94%) of the 40 women in group 1 and 38 (95%; 95% CI 85%, 99%) of the 40 women in group 2 had complete abortions. Overall, complete abortion without surgical intervention occurred in 34 women in group 1 (85%; 95% CI 71%, 94%) and 40 women in group 2 (100%; 95% CI 91%, 100%; P = .03). Four women in group 1 required suction aspiration for continuing pregnancy at the second follow-up, compared with none in group 2 (P = .12). Side effects occurred with similar frequency in both treatment groups.

CONCLUSION:

Low-dose mifepristone (100 mg) combined with vaginal misoprostol 800 μg may be an effective alternative to regimens using 200 or 600 mg of mifepristone with misoprostol.

Section snippets

Materials and methods

This clinical trial was approved by the Institutional Review Board of Magee-Womens Hospital of the University of Pittsburgh Health System. Entry criteria included 1) age at least 18 years, 2) a singleton intrauterine pregnancy not exceeding 49 days’ gestation as documented by vaginal ultrasound, 3) request for an abortion, 4) willingness to comply with the visit schedule, 5) willingness to have a surgical abortion if indicated, 6) adequate venous access for multiple phlebotomies, and 7) access

Results

Patient characteristics are presented in Table 1. All 80 subjects used the misoprostol, although histories obtained at first follow-up suggested that two women in group 1 and one woman in group 2 might have aborted before using the misoprostol. All but one of the women in group 1 (98%) and 38 (95%) of the women in group 2 used the misoprostol 48 hours ± 30 minutes after administration of mifepristone. The three women who did not use misoprostol during this time inserted the misoprostol tablets

Discussion

Mifepristone at doses less than the 600 mg, standardly used throughout most of the world, is known to be clinically effective. Two randomized studies demonstrated equal efficacy of regimens using either 200 or 600 mg of mifepristone followed in 48 hours by a misoprostol dose of 400 μg orally6 or 600 μg orally.7 In addition, a retrospective analysis by Ashok et al8 of data from 2000 women using mifepristone 200 mg followed in 48 hours by misoprostol 800 μg vaginally demonstrated complete

References (28)

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Supported by the Departmental Research Fund, Magee-Women’s Research Institute Family Planning Research Fund.

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