Open AccessEffectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal
Author(s) -
Corinne H. Rocca,
Mahesh Puri,
Prabhakar Shrestha,
Maya Blum,
Dev Maharjan,
Daniel Grossman,
Krishna Regmi,
Philip D. Darney
Publication year - 2018
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0191174
Subject(s) - misoprostol , medicine , pharmacy , abortion , vacuum aspiration , psychological intervention , obstetrics , medical abortion , unsafe abortion , incomplete abortion , family medicine , nursing , pregnancy , family planning , population , environmental health , genetics , research methodology , biology
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.