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Review
. 2017 Oct;124(11):1646-1652.
doi: 10.1111/1471-0528.14646. Epub 2017 Apr 27.

A research agenda for moving early medical pregnancy termination over the counter

N Kapp  1 , D Grossman  2 , E Jackson  3 , L Castleman  1 , D Brahmi  1
Affiliations
Review

A research agenda for moving early medical pregnancy termination over the counter

N Kapp et al. BJOG. 2017 Oct.

Abstract

Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone-misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over-the-counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self-use of medical termination, the critical elements missing are the label comprehension, self-selection and actual use studies.

Tweetable abstract: Considering medical pregnancy termination through the over-the-counter regulatory lens clarifies critical evidence gaps.

Keywords: First trimester; medical termination of pregnancy; mifepristone; misoprostol; over-the-counter; pregnancy termination.

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References

    1. Bracken H, Clark W, Lichtenberg ES, Schweikert SM, Tanenhaus J, Barajas A, et al. Alternatives to routine ultrasound for eligibility assessment prior to early termination of pregnancy with mifepristone‐misoprostol. BJOG 2011;118:17–23. - PubMed
    1. Paul M, Iyengar K, Essén B, Gemzell‐Danielsson K, Iyengar SD, Bring J, et al. Acceptability of home‐assessment post medical abortion and medical abortion in a low‐resource setting in Rajasthan, India. Secondary outcome analysis of a non‐inferiority randomized controlled trial. PLoS ONE 2015;10:e0133354. - PMC - PubMed
    1. Michie L, Cameron ST. Simplified follow‐up after early medical abortion: 12‐month experience of a telephone call and self‐performed low‐sensitivity urine pregnancy test. Contraception 2014;89:440–5. - PubMed
    1. Blum J, Shochet T, Lynd K, Lichtenberg ES, Fischer D, Arnesen M, et al. Can at‐home semi‐quantitative pregnancy tests serve as a replacement for clinical follow‐up of medical abortion? A US study Contraception 2012;86:757–62. - PubMed
    1. World Health Organization . Safe Abortion: Technical and Policy Guidance for Health Systems. Geneva: World Health Organization, 2012. - PubMed

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