Comparison of the Safety of First Trimester Abortions Performed by Physicians and Non-Physicians in South Africa and Viet Nam.

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370487
• Other study ID #: A15324;A15325
• Status: Completed
• Phase: N/A
• First received: August 30, 2006
• Last updated: September 5, 2006
• Start date: September 2003
• Est. completion date: June 2004

Study information

• Verified date: June 2005
• Source: World Health Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: World Health Organization
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2860
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• gestation of no more than 12 weeks as estimated by pelvic examination and date of LMP

• age 18 or above

• residence within the catchment area specified for each clinic

• willing to return to clinic for follow-up visit or agree to a telephone or home-based interview

• be able to understand the information given to them and to make personal decisions on whether or not to participate in the study as determined by the study staff

• consent given to participate in the study and consent form signed

Exclusion Criteria:

• uterine sizing of beyond 12 weeks gestation

• under age 18

• unwilling or unable to return to clinic for follow-up visit.

• unwilling to provide consent for participation in the study

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abortion, Induced

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
World Health Organization	National Obstetrics and Gynecology Hospital, Hanoi, VietNam, University of Cape Town