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

5 september 2006 uppdaterad av: World Health Organization

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning

2860

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: 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
  • Huvudutredare: ND Vy, MD, National Hospital of Obstetrics and Gynecology, 43 Trang Thi, Hanoi, Viet Nam
  • Studierektor: My Huong Nguyen, MD, National Hospital of Obstetrics and Gynecology, 43 Trang Thi, Hanoi, Viet Nam
  • Studierektor: 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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2003

Avslutad studie

1 juni 2004

Studieregistreringsdatum

Först inskickad

30 augusti 2006

Först inskickad som uppfyllde QC-kriterierna

30 augusti 2006

Första postat (Uppskatta)

31 augusti 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 september 2006

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 september 2006

Senast verifierad

1 juni 2005

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • A15324;A15325

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