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

Mitchell D. Creinin, Courtney A. Schreiber, Paula Bednarek, Hanna Lintu, Marie Soleil Wagner, Leslie A. Meyn

Research output: Contribution to journalArticle

75 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)885-894
Number of pages10
JournalObstetrics and Gynecology
Volume109
Issue number4
DOIs
StatePublished - Apr 2007
Externally publishedYes

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Misoprostol
Mifepristone
Randomized Controlled Trials
Induced Abortion
Pregnancy
Confidence Intervals
Group Homes
Chills
Suction
Nausea
Gestational Age
Diarrhea
Ultrasonography
Therapeutics
Clinical Trials

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion : A randomized controlled trial. / Creinin, Mitchell D.; Schreiber, Courtney A.; Bednarek, Paula; Lintu, Hanna; Wagner, Marie Soleil; Meyn, Leslie A.

In: Obstetrics and Gynecology, Vol. 109, No. 4, 04.2007, p. 885-894.

Research output: Contribution to journalArticle

Creinin, Mitchell D. ; Schreiber, Courtney A. ; Bednarek, Paula ; Lintu, Hanna ; Wagner, Marie Soleil ; Meyn, Leslie A. / Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion : A randomized controlled trial. In: Obstetrics and Gynecology. 2007 ; Vol. 109, No. 4. pp. 885-894.
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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.",
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