NCT00370487

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,860

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
Last Updated

September 6, 2006

Status Verified

June 1, 2005

First QC Date

August 30, 2006

Last Update Submit

September 5, 2006

Conditions

Abortion, Induced

Keywords

AbortionMidlevel providersSouth AfricaViet Nam

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • 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.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

September 1, 2003

Study Completion

June 1, 2004

Last Updated

September 6, 2006

Record last verified: 2005-06