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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 septembre 2006 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription

2860

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: 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
  • Chercheur principal: ND Vy, MD, National Hospital of Obstetrics and Gynecology, 43 Trang Thi, Hanoi, Viet Nam
  • Directeur d'études: My Huong Nguyen, MD, National Hospital of Obstetrics and Gynecology, 43 Trang Thi, Hanoi, Viet Nam
  • Directeur d'études: 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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2003

Achèvement de l'étude

1 juin 2004

Dates d'inscription aux études

Première soumission

30 août 2006

Première soumission répondant aux critères de contrôle qualité

30 août 2006

Première publication (Estimation)

31 août 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 septembre 2006

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 septembre 2006

Dernière vérification

1 juin 2005

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • A15324;A15325

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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