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

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.

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

SUBMITTER: Kapp N

PROVIDER: S-EPMC5637897 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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

Kapp N N Grossman D D Jackson E E Castleman L L Brahmi D D

BJOG : an international journal of obstetrics and gynaecology 20170427 11

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 i ...[more]

PMID: 28317327

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Project description:BackgroundA wide range of drugs have been studied for first trimester medical abortion. Studies evaluating different regimens, including combination mifepristone and misoprostol and misoprostol alone regimens, show varying results related to safety, efficacy and other outcomes. Thus, the objectives of this systematic review were to compare the safety, effectiveness and acceptability of medical abortion and to compare medical with surgical methods of abortion ≤63 days of gestation.MethodsPubmed and EMBASE were systematically searched from database inception through January 2019 using a combination of MeSH, keywords and text words. Randomized controlled trials on induced abortion at ≤63 days that compared different regimens of medical abortion using mifepristone and/or misoprostol and trials that compared medical with surgical methods of abortion were included. We extracted data into a pre-designed form, calculated effect estimates, and performed meta-analyses where possible. The primary outcomes were ongoing pregnancy and successful abortion.ResultsThirty-three studies composed of 22,275 participants were included in this review. Combined regimens using mifepristone and misoprostol had lower rates of ongoing pregnancy, higher rates of successful abortion and satisfaction compared to misoprostol only regimens. In combined regimens, misoprostol 800 μg was more effective than 400 μg. There was no significant difference in dosing intervals between mifepristone and misoprostol and routes of misoprostol administration in combination or misoprostol alone regimens. The rate of serious adverse events was generally low.ConclusionIn this systematic review, we find that medical methods of abortion utilizing combination mifepristone and misoprostol or misoprostol alone are effective, safe and acceptable. More robust studies evaluating both the different combination and misoprostol alone regimens are needed to strengthen existing evidence as well as assess patient perspectives towards a particular regimen.

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

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Publications

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

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