Abortion, Induced Clinical Trial
Official title:
Complication Rates of First-Trimester Manual Vacuum Aspiration Abortion Performed by Physicians and Midlevel Providers (MLP) in South Africa and Viet Nam: a Randomised, Controlled, Equivalence Trial.
There have been no studies in developing countries assessing the safety of midlevel providers (MLP) compared to physicians in performing first-trimester manual vacuum aspiration abortion. In South Africa and Viet Nam, MLP (midwives and physician assistants) are trained and accredited to perform first trimester abortions to increase women’s access to safe abortion services. To assess the safety of abortions performed by midlevel provider compared to physicians, complication rates of first-trimester manual vacuum aspiration are compared between types of providers in the two countries. We test the null hypothesis that the two types of providers provide abortions equally safely.
Objective
There have been no studies in developing countries assessing the safety of midlevel
providers (MLP) compared to physicians in performing first-trimester manual vacuum
aspiration abortion. In South Africa and Viet Nam, MLP (midwives and physician assistants)
are trained and accredited to perform first trimester abortions to increase women’s access
to safe abortion services. Complication rates of first-trimester manual vacuum aspiration
are compared between types of providers in the two countries.
Methods:
A randomized, two-sided controlled equivalence trial was conducted to compare rates of
abortion complications. An a priori margin of equivalence of 4.5% with 80% power and a 95%
CI ( = 0.025) was used. Women presenting for an induced abortion at up to 12 weeks’
gestation were randomly assigned to a physician or a midlevel provider for manual vacuum
aspiration and followed-up 10 to 14 days later. Complications were recorded during the
abortion procedure, before discharge from the clinic and at follow-up. The study included 25
providers and 2894 cases, 1160 in South Africa and 1734 in Viet Nam.
Results:
Complication rates were 1.4 per 100 for MLP and 0 for physicians in South Africa. In Viet
Nam, complication rates were 1.2 per 100 for MLP and 1.1 per 100 for physicians. In both
countries, complication rates satisfied the pre-determined statistical criteria for
equivalence. In South Africa, the difference in complication rates for mid-level providers
and physicians was 1.4 per 100 (CI=0.4 to 2.7). In Viet Nam, the difference in complication
rates for mid-level providers and physicians was 0.1 per 100 (CI= -1.0 to 1.2). There were
no major immediate complications. Delayed complications were retained products and
infection.
Conclusions:
First trimester manual vacuum aspiration abortions performed by trained and accredited
midlevel providers in South Africa and Viet Nam were comparable in safety to those performed
by physicians. Given appropriate training, midlevel health care providers can provide first
trimester manual vacuum aspiration abortions as safely as physician abortion providers.
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Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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