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.
Verified date | June 2005 |
Source | World Health Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: World Health Organization |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2860 |
Est. completion date | June 2004 |
Est. primary completion date | |
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 |
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
World Health Organization | National Obstetrics and Gynecology Hospital, Hanoi, VietNam, University of Cape Town |
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