Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Oct 10;7(10):e016157.
doi: 10.1136/bmjopen-2017-016157.

Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya

Marlene Makenzius  1   2 , Monica Oguttu  3 , Marie Klingberg-Allvin  4   5 , Kristina Gemzell-Danielsson  6   7 , Theresa M A Odero  8 , Elisabeth Faxelid  1
Affiliations
Randomized Controlled Trial

Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya

Marlene Makenzius et al. BMJ Open. .

Abstract

Objective: To assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians.

Design: A multicentre randomised controlled equivalence trial. The study was not masked.

Settings: Gynaecological departments in two hospitals in a low-resource setting, Kenya.

Population: Women (n=1094) with incomplete abortion in the first trimester, seeking PAC between 1 June 2013 to 31 May 2016. Participants were randomly assigned to receive treatment from midwives or physicians. 409 and 401 women in the midwife and physician groups, respectively, were included in the per-protocol analysis.

Interventions: 600 µg misoprostol orally, and contraceptive counselling by a physician or midwife.

Main outcome measures: Complete abortion not needing surgical intervention within 7-10 days. The main outcome was analysed on the per-protocol population with a generalised estimating equation model. The predefined equivalence range was -4% to 4%. Secondary outcomes were analysed descriptively.

Results: The proportion of complete abortion was 94.8% (768/810): 390 (95.4%) in the midwife group and 378 (94.3%) in the physician group. The proportion of incomplete abortion was 5.2% (42/810), similarly distributed between midwives and physicians. The model-based risk difference for midwives versus physicians was 1.0% (-4.1 to 2.2). Most women felt safe (97%; 779/799), and 93% (748/801) perceived the treatment as expected/easier than expected. After contraceptive counselling the uptake of a contraceptive method after 7-10 days occurred in 76% (613/810). No serious adverse events were recorded.

Conclusions: Treatment of incomplete abortion with misoprostol provided by midwives is equally effective, safe and accepted by women as when administered by physicians in a low-resource setting. Systematically provided contraceptive counselling in PAC is effective to mitigate unmet need for contraception.

Trial registration number: NCT01865136; Results.

Keywords: Community Gynaecology; Health Policy; Maternal Medicine; Reproductive Medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Trial profile.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Sedgh G, Bearak J, Singh S, et al. . Abortion incidence between 1990 and 2014: global, regional, and subregional levels and trends. Lancet 2016;388:258–67. 10.1016/S0140-6736(16)30380-4 - DOI - PMC - PubMed
    1. Ziraba AK, Izugbara C, Levandowski BA, et al. . Unsafe abortion in Kenya: a cross-sectional study of abortion complication severity and associated factors. BMC Pregnancy Childbirth 2015;15:34 10.1186/s12884-015-0459-6 - DOI - PMC - PubMed
    1. Safe abortion: technical and policy guidance for health systems, second edition 12. Geneva: World Health Organization, 2012. http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf (accessed 20 Jul 2017). - PubMed
    1. Singh S. Hospital admissions resulting from unsafe abortion: estimates from 13 developing countries. Lancet 2006;368:1887–92. 10.1016/S0140-6736(06)69778-X - DOI - PubMed
    1. Mayi-Tsonga S, Oksana L, Ndombi I, et al. . Delay in the provision of adequate care to women who died from abortion-related complications in the principal maternity hospital of Gabon. Reprod Health Matters 2009;17:65–70. 10.1016/S0968-8080(09)34465-1 - DOI - PubMed

Publication types

MeSH terms

Substances

Associated data