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Original Research Article| Volume 101, ISSUE 5, P302-308, May 2020

A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64–70 days and 71–77 days of gestation

Published:January 31, 2020DOI:https://doi.org/10.1016/j.contraception.2020.01.009
A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64–70 days and 71–77 days of gestation
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      Abstract

      Objectives

      This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64–70 days and 71–77 days of gestation.

      Study design

      We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64–77 days’ gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24–48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability.

      Results

      Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71–77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar.

      Conclusion

      Although the success rate at 71–77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71–77 days.

      Keywords

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      Article info

      Publication history

      Published online: January 31, 2020
      Accepted: January 20, 2020
      Received in revised form: December 21, 2019
      Received: August 10, 2019

      Footnotes

      ☆Funding: This work was supported by an Anonymous donor. The funding source had no involvement in study conduct, analysis or write-up.

      ☆☆Declaration of interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

      ★IRB approval: IRB approval was granted by The New England Institutional Review Board, Cook County Health and Hospitals System IRB, and local ethical committees in Mexico, Vietnam, Azerbaijan and Republic of Georgia.

      Identification

      DOI: https://doi.org/10.1016/j.contraception.2020.01.009

      Copyright

      © 2020 Elsevier Inc. All rights reserved.

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