Comparison of the Safety of First Trimester Abortions Performed by Physicians and Non-Physicians in South Africa and Viet Nam.
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|ClinicalTrials.gov Identifier: NCT00370487|
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : September 6, 2006
|Condition or disease|
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.
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.
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||2860 participants|
|Observational Model:||Defined Population|
|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.|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||June 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370487
|Principal Investigator:||Margaret Hoffman, M.D.||Women’s Health Research Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa|
|Principal Investigator:||ND Vy, MD||National Hospital of Obstetrics and Gynecology, 43 Trang Thi, Hanoi, Viet Nam|
|Study Director:||My Huong Nguyen, MD||National Hospital of Obstetrics and Gynecology, 43 Trang Thi, Hanoi, Viet Nam|
|Study Director:||Jane Harries, PhD||Women’s Health Research Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.|