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

August 20, 2010 updated by: World Health Organization

Comparison of the Safety, Efficacy, and Feasibility of Medical Abortion Provided by Physicians and Non-physicians in Nepal: a Randomized Controlled, Equivalence Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each year, some 210 million women throughout the world become pregnant and nearly one in five chooses to terminate the pregnancy (Singh et al., 2009). Approximately, 22 million pregnancies are terminated unsafely; of these, the vast majority (98%) take place in developing countries (WHO, Forthcoming). Access to safe abortion services is a challenge for many women with unwanted pregnancies in developing countries because of restrictive legislation, a shortage of skilled staff or other barriers.

Non-surgical methods of abortion, known as medical abortion, have been developed that use safe and effective drug-based methods for induced abortion. Prescribing authority is generally limited to doctors, however. As a result, medical abortion remains under-utilized and is often inaccessible for many women in developing countries seeking public sector providers trained in medical abortion in areas where there are no doctors.

Midlevel providers (non-physician clinicians such as nurses and midwives) have the potential to provide accessible, low-cost, and safe abortion services in many countries, especially in the developing world. They are more cost-effective to employ than doctors and often work in areas where doctors are in short supply, providing much needed health services to under-served areas while conserving resources. Training midlevel providers in the independent provision of medical abortion with appropriate referral systems would expand access to safe abortion services to lower levels of the health care system where there is no doctor and complement a global health systems trend towards task-shifting where doctors are costly and scarce (WHO, 2007).

The overall objective of the study is to obtain evidence on the safety and effectiveness of medical abortions performed by government trained and certified midlevel providers and physicians to inform policy makers interested in or committed to expanding and decentralizing medical abortion services.

Study Type

Interventional

Enrollment (Actual)

1104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Center for Research and Environmental Health and Population Activities (CREHPA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Before randomization: Gestational age not more than 63 days as estimated by last menstrual period (LMP).
  • After randomization: Gestational age not more than 63 days as estimated by abdominal and bimanual pelvic examination.
  • Above national age of consent
  • Willing to return to the clinic for misoprostol on Day 3 and for a follow-up visit on Day 10 to 14.
  • Residence within the geographical area specified for each clinic and no more than one hour from emergency referral services.
  • Willing to provide written informed consent to participate in the study and to be randomly assigned to a provider team.
  • Able to understand the nature of the study, advice and instructions given by health providers.

Exclusion Criteria:

  • Previous allergic reaction to one of the drugs in the medical abortion regimen
  • Known or suspected ectopic pregnancy or undiagnosed adnexal mass
  • Inherited porphyria (rare genetic blood diseases)
  • Chronic adrenal failure
  • Long term corticosteroid therapy
  • Haemorrhagic disorder or anticoagulant therapy (blood thinner medications)
  • IUD in utero that can not be removed before taking mifepristone
  • Previous enrolment in the study (i.e. no repeat abortions; only one abortion per woman in the study)
  • Unwilling or unable to return to clinic for follow-up visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Midlevel provider
Patients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion.
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.
Other: Physician arm
Patients were assigned to a midlevel provider (arm 1) or to a physician (arm 2) for their abortion.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion
Time Frame: 30 days
The primary outcome measure was a successful (complete) abortion, defined as no ongoing pregnancy at clinical examination and no surgical intervention necessary.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications from medical abortion
Time Frame: 30 days
Defined as life-threatening events requiring hospitalization: haemorrhage requiring a blood transfusion, hospitalization (iv fluids, iv antibiotics), or laparatomy for ectopic pregnancies.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

World Health Organization

Collaborators

Center for Research and Environmental Health and Population Activities (CREHPA)

Investigators

  • Principal Investigator: Kusum Thapa, MD, Department of Obstetrics and Gynaecology, Paropakar Maternity and Women Hospital (Maternity Hospital), Kathmandu, Nepal
  • Study Director: Ina Warriner, PhD, World Health Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 23, 2010

Last Update Submitted That Met QC Criteria

August 20, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WHO A65550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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