Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

5. september 2006 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering

2860

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2003

Studiet fullført

1. juni 2004

Datoer for studieregistrering

Først innsendt

30. august 2006

Først innsendt som oppfylte QC-kriteriene

30. august 2006

Først lagt ut (Anslag)

31. august 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. september 2006

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2006

Sist bekreftet

1. juni 2005

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • A15324;A15325

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere