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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

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