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Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial.

Abstract：

OBJECTIVE:Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial to compare the efficacy, adverse effects, and acceptability of misoprostol 800 mcg vaginally administered simultaneously with, or 24 hours after, mifepristone 200 mg orally for abortion in women up to 63 days of gestation. METHODS:The 1,128 participants swallowed mifepristone 200 mg and were then randomized to self-administer misoprostol intravaginally immediately in the office (group 1) or 24 hours later at home (group 2). Subjects returned for an evaluation, including transvaginal ultrasonography, 7+/-1 days after initiating treatment. Women who had not aborted were offered a second dose of misoprostol and returned for another evaluation in approximately 1 week. A phone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication. RESULTS:The complete abortion rate for group 1 (95.1%, 95% confidence interval [CI] 93.0-96.8%) was statistically noninferior to that for group 2 (96.9%, 95% CI 95.1-98.2%) (P=.003). The abortion rates between groups did not significantly differ by gestational age. Adverse effects were mostly similar, although nausea, diarrhea, and warmth or chills were significantly more common in group 1. CONCLUSION:Mifepristone 200 mg and misoprostol 800 mcg vaginally used simultaneously is as effective for abortion as compared with regimens using a 24-hour dosing interval. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269568 LEVEL OF EVIDENCE:I.

journal_name

Obstet Gynecol

journal_title

Obstetrics and gynecology

authors

Creinin MD,Schreiber CA,Bednarek P,Lintu H,Wagner MS,Meyn LA,Medical Abortion at the Same Time (MAST) Study Trial Group.

doi

10.1097/01.AOG.0000258298.35143.d2

subject

Has Abstract

pub_date

2007-04-01 00:00:00

pages

885-94

issue

eissn

0029-7844

issn

1873-233X

pii

109/4/885

journal_volume

109

pub_type

杂志文章,多中心研究,随机对照试验

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Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial.