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Comparison of the Safety and Efficacy of Medical Abortion Provided by Physicians and Midlevel Providers in Nepal

NCT01186302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1104

Last updated 2010-08-23

No results posted yet for this study

Summary

The purpose of the study is to compare the safety, effectiveness, and acceptability of medical abortion provided by doctors and midlevel providers in a developing country where doctors are scarce, such as Nepal. This study is the first to evaluate the independent provision of medical abortion by trained nurses and auxiliary nurse midwives compared to doctors by assessing differences in safety, clinical outcomes, case management decision-making, and acceptability. This study provides scientifically valid data on the administration of medical abortion by midlevel providers working independently in a low-resource, developing country setting. The evidence generated by the study will assist policy makers in developing countries interested in expanding safe abortion services by eliminating the legal requirement limiting prescription of medical abortion to doctors where medical abortion is not restricted by law.

Conditions

  • Medical Abortion

Interventions

OTHER

Type of provider

Different types of clinicians have different types of medical training. This study tested whether midlevel providers were as safe and effective in administering medical abortion as doctors. All types of providers underwent the same training in medical abortion and used the same medical abortion regimen.

Sponsors & Collaborators

  • Center for Research on Environment, Health and Population Activities

    collaborator OTHER

  • World Health Organization

    lead OTHER

Principal Investigators

  • Kusum Thapa, MD · Department of Obstetrics and Gynaecology, Paropakar Maternity and Women Hospital (Maternity Hospital), Kathmandu, Nepal

  • Ina Warriner, PhD · World Health Organization

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-03-31
Completion
2010-07-31

Countries

  • Nepal

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186302 on ClinicalTrials.gov