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.
Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Steroidal/administration & dosage , Abortion, Induced/methods , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Pregnancy Trimester, First , Abortion, Induced/ethics , Drug Approval , Drug Therapy, Combination , Female , Health Knowledge, Attitudes, Practice , Humans , Nonprescription Drugs , Pregnancy , United States , United States Food and Drug AdministrationABSTRACT
BACKGROUND: Unsafe termination of pregnancy is a major contributor to maternal morbidity and mortality. Task sharing termination of pregnancy services between physicians and mid-level providers, a heterogeneous group of trained healthcare providers, such as nurses, midwives and physician assistants, has become a key strategy to increase access to safe pregnancy termination care. OBJECTIVES: To systematically review the evidence to assess whether termination of pregnancy services by nonphysician providers can be performed safely and effectively. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, MEDLINE in process and other nonindexed citations and POPLINE. SELECTION CRITERIA: We included randomised controlled trials (RCTs), as well as clinical studies, using study designs that compared efficacy, safety and acceptability of termination of pregnancy services by physicians versus other provider groups. Data collection and analysis Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using RevMan. Quality assessment of the data used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: We identified five controlled studies comprising 8908 women undergoing first-trimester surgical termination of pregnancy (one RCT and three prospective cohort studies) and medical termination of pregnancy (one RCT). The mid-level provider group included midwives, nurses, auxiliary nurse midwives and physician assistants trained in termination of pregnancy services. Safety and efficacy outcomes, including incomplete termination of pregnancy, haemorrhage, injury to the uterus or cervix, did not differ significantly between providers. AUTHOR'S CONCLUSIONS: Limited evidence indicates that trained mid-level providers may effectively and safely provide first-trimester surgical and medical termination of pregnancy services. Data are limited by the scarcity of RCTs and biases of the cohort studies.
