Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal

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Abstract

Background

Expanding access to medication abortion through pharmacies is a promising avenue to reach women with safe and convenient care, yet no pharmacy provision interventions have been evaluated. This observational non-inferiority study investigated the effectiveness and safety of mifepristone-misoprostol medication abortion provided at pharmacies, compared to government-certified public health facilities, by trained auxiliary nurse-midwives in Nepal.

Methods

Auxiliary nurse-midwives were trained to provide medication abortion through twelve pharmacies and public facilities as part of a demonstration project in two districts. Eligible women were ≤63 days pregnant, aged 16–45, and had no medical contraindications. Between 2014–2015, participants (n = 605) obtained 200 mg mifepristone orally and 800 μg misoprostol sublingually or intravaginally 24 hours later, and followed-up 14–21 days later. The primary outcome was complete abortion without manual vacuum aspiration; the secondary outcome was complication requiring treatment. We assessed risk differences by facility type with multivariable logistic mixed-effects regression.

Results

Over 99% of enrolled women completed follow-up (n = 600). Complete abortions occurred in 588 (98·0%) cases, with ten incomplete abortions and two continuing pregnancies. 293/297 (98·7%) pharmacy participants and 295/303 (97·4%) public facility participants had complete abortions, with an adjusted risk difference falling within the pre-specified 5 percentage-point non-inferiority margin (1·5% [-0·8%, 3·8%]). No serious adverse events occurred. Five (1.7%) pharmacy and two (0.7%) public facility participants experienced a complication warranting treatment (aRD, 0.8% [-1.0%-2.7%]).

Conclusions

Early mifepristone-misoprostol abortion was as effective and safe when provided by trained auxiliary nurse-midwives at pharmacies as at government-certified health facilities. Findings support policy expanding provision through registered pharmacies by trained auxiliary nurse-midwives to improve access to safe care.

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Most cited references 27

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Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

Nicholas J. Kassebaum, Amelia Bertozzi-Villa, Megan S Coggeshall … (2014)

The fifth Millennium Development Goal (MDG 5) established the goal of a 75% reduction in the maternal mortality ratio (MMR; number of maternal deaths per 100,000 livebirths) between 1990 and 2015. We aimed to measure levels and track trends in maternal mortality, the key causes contributing to maternal death, and timing of maternal death with respect to delivery. We used robust statistical methods including the Cause of Death Ensemble model (CODEm) to analyse a database of data for 7065 site-years and estimate the number of maternal deaths from all causes in 188 countries between 1990 and 2013. We estimated the number of pregnancy-related deaths caused by HIV on the basis of a systematic review of the relative risk of dying during pregnancy for HIV-positive women compared with HIV-negative women. We also estimated the fraction of these deaths aggravated by pregnancy on the basis of a systematic review. To estimate the numbers of maternal deaths due to nine different causes, we identified 61 sources from a systematic review and 943 site-years of vital registration data. We also did a systematic review of reports about the timing of maternal death, identifying 142 sources to use in our analysis. We developed estimates for each country for 1990-2013 using Bayesian meta-regression. We estimated 95% uncertainty intervals (UIs) for all values. 292,982 (95% UI 261,017-327,792) maternal deaths occurred in 2013, compared with 376,034 (343,483-407,574) in 1990. The global annual rate of change in the MMR was -0·3% (-1·1 to 0·6) from 1990 to 2003, and -2·7% (-3·9 to -1·5) from 2003 to 2013, with evidence of continued acceleration. MMRs reduced consistently in south, east, and southeast Asia between 1990 and 2013, but maternal deaths increased in much of sub-Saharan Africa during the 1990s. 2070 (1290-2866) maternal deaths were related to HIV in 2013, 0·4% (0·2-0·6) of the global total. MMR was highest in the oldest age groups in both 1990 and 2013. In 2013, most deaths occurred intrapartum or postpartum. Causes varied by region and between 1990 and 2013. We recorded substantial variation in the MMR by country in 2013, from 956·8 (685·1-1262·8) in South Sudan to 2·4 (1·6-3·6) in Iceland. Global rates of change suggest that only 16 countries will achieve the MDG 5 target by 2015. Accelerated reductions since the Millennium Declaration in 2000 coincide with increased development assistance for maternal, newborn, and child health. Setting of targets and associated interventions for after 2015 will need careful consideration of regions that are making slow progress, such as west and central Africa. Bill & Melinda Gates Foundation. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Unsafe abortion: the preventable pandemic.

David A Grimes, Janie Benson, Susheela Singh … (2006)

Ending the silent pandemic of unsafe abortion is an urgent public-health and human-rights imperative. As with other more visible global-health issues, this scourge threatens women throughout the developing world. Every year, about 19-20 million abortions are done by individuals without the requisite skills, or in environments below minimum medical standards, or both. Nearly all unsafe abortions (97%) are in developing countries. An estimated 68 000 women die as a result, and millions more have complications, many permanent. Important causes of death include haemorrhage, infection, and poisoning. Legalisation of abortion on request is a necessary but insufficient step toward improving women's health; in some countries, such as India, where abortion has been legal for decades, access to competent care remains restricted because of other barriers. Access to safe abortion improves women's health, and vice versa, as documented in Romania during the regime of President Nicolae Ceausescu. The availability of modern contraception can reduce but never eliminate the need for abortion. Direct costs of treating abortion complications burden impoverished health care systems, and indirect costs also drain struggling economies. The development of manual vacuum aspiration to empty the uterus, and the use of misoprostol, an oxytocic agent, have improved the care of women. Access to safe, legal abortion is a fundamental right of women, irrespective of where they live. The underlying causes of morbidity and mortality from unsafe abortion today are not blood loss and infection but, rather, apathy and disdain toward women.

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Facility-based treatment for medical complications resulting from unsafe pregnancy termination in the developing world, 2012: a review of evidence from 26 countries

S. Singh, I Maddow-Zimet (2015)

With changing conditions affecting receipt of postabortion care, an updated estimate of the incidence of treatment for complications from unsafe pregnancy termination is needed to inform policies and programmes. National estimates of facility-based treatment for complications in 26 countries form the basis for estimating treatment rates in the developing world. An estimated seven million women were treated in the developing world for complications from unsafe pregnancy termination in 2012, a rate of 6.9 per 1000 women aged 15–44 years. Regionally, rates ranged from 5.3 in Latin America and the Caribbean to 8.2 in Asia. Results inform policies to improve women’s health.

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Author and article information

Contributors

Corinne H. Rocca:

ORCID: http://orcid.org/0000-0001-9892-249X

Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Mahesh Puri: Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: SupervisionRole: Writing – review & editing

Prabhakar Shrestha: Role: Data curationRole: InvestigationRole: Project administrationRole: Writing – review & editing

Maya Blum: Role: InvestigationRole: Project administrationRole: Writing – review & editing

Dev Maharjan: Role: Data curationRole: Project administrationRole: Writing – review & editing

Daniel Grossman: Role: SupervisionRole: Writing – review & editing

Kiran Regmi: Role: InvestigationRole: Writing – review & editing

Philip D. Darney: Role: ResourcesRole: SupervisionRole: Writing – review & editing

Cynthia C. Harper: Role: Funding acquisitionRole: SupervisionRole: Writing – review & editing

Sten H. Vermund: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 19 January 2018

Publication date Collection: 2018

Volume: 13

Issue: 1

Electronic Location Identifier: e0191174

Affiliations

[1 ] Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of California San Francisco, San Francisco, CA, United States of America

[2 ] Advancing New Standards in Reproductive Health (ANSIRH), Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of California San Francisco, Oakland, CA, United States of America

[3 ] Center for Research on Environment Health & Population Activities (CREHPA), Kusunti, Lalitpur, Kathmandu, Nepal

[4 ] Ministry of Health, Kathmandu, Nepal

Yale University Yale School of Public Health, UNITED STATES

Author notes

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: corinne.rocca@ 123456ucsf.edu

Author information

Corinne H. Rocca http://orcid.org/0000-0001-9892-249X

Article

Publisher ID: PONE-D-17-12342

DOI: 10.1371/journal.pone.0191174

PMC ID: 5774715

PubMed ID: 29351313

SO-VID: a801844f-011c-4675-b525-8aa7fb5133ba

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 29 March 2017

Date accepted : 27 December 2017

Page count

Figures: 1, Tables: 3, Pages: 12

Funding

Funded by: Society of Family Planning Research Fund

Award ID: SFPRF7-1

Award Recipient :

ORCID: http://orcid.org/0000-0001-9892-249X

Corinne H. Rocca

The Society of Family Planning Research Fund supported this study (grant: SFPRF7-1, http://www.societyfp.org/Research-and-grants.aspx). The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Data Availability The authors are unable to make their data available in a public repository due to ethical restrictions, including the sensitive nature of the study topic (abortion) and particular privacy concerns for participants who are classified by the UCSF IRB as a vulnerable population (pregnant women, illiterate women, seeking a stigmatized service). De-identified data used to make the conclusions for this study will be made available upon written request to the first author ( corinne.rocca@ 123456ucsf.edu ) or Sarah Raifman ( sarah.raifman@ 123456ucsf.edu ) after obtaining the necessary ethical approvals.

Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal

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Most cited references 27

Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

Unsafe abortion: the preventable pandemic.

Facility-based treatment for medical complications resulting from unsafe pregnancy termination in the developing world, 2012: a review of evidence from 26 countries

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