Task Sharing to Improve Post Abortion Care at District Health Care Level- Trial in Uganda

August 27, 2014 updated by: Kristina Gemzell Danielsson, Karolinska Institutet
Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women's access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1010

Phase

  • Phase 4

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

  • Uganda
      • Kampala, Uganda
        • Mulago Hospital

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

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • bleeding and contractions during pregnancy

Exclusion Criteria:

  • women with known allergy to misoprostol,
  • a uterine size more than 12 weeks of gestation,
  • suspected ectopic pregnancy,
  • unstable hemodynamic status and chock,
  • signs of pelvic infection and/or sepsis.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: misoprostol by midwife
Women with incomplete abortion is diagnosed and treated with misoprostol by midwife
Other: misoprostol by midwife
Women with incomplete abortion is diagnosed and treated with misoprostol by midwife
NO_INTERVENTION: Misoprostol by physician
Women with incomplete abortion is diagnosed and treated with misoprostol by physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion
Time Frame: 14 days
The clinical assessments of the main outcome are: (i) Physical examination (pulse, blood pressure and temperature); (ii) Pelvic examination that includes examination of size of the uterus (external genitalia, speculum examination, bimanual examination).
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding
Time Frame: 14 days
Measurements of secondary outcomes are: (i) symptom diary card used by women to assess daily bleeding . The intensity of bleeding will be self-reported by the women in relation to normal menstrual bleeding (categorised 1=much less than up to 5= much heavier than).
14 days
pain
Time Frame: 14 days
Measurements of secondary outcomes are: (i) symptom diary card used by women to assess pain. Pain reported using visual analogue scale (VAS). before any use of analgesia.
14 days
acceptability
Time Frame: 14 days
Standardized questionnaires will be used to collect information about women's acceptability and experiences of the treatment and time spent on travelling and on clinical visits following treatment.
14 days
un-scheduled visits
Time Frame: 14 days
Standardized questionnaires will be used to collect information about women's time spent on travelling and on clinical visits following treatment.
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
contraceptive up take
Time Frame: 14 days
Standardized questionnaires will be used to collect information about women's pre and post contraceptive uptake.
14 days

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

Makerere University

Investigators

  • Principal Investigator: Josaphat Byamugisha, MD, PhD, Makerere University

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, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (ESTIMATE)

May 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tasksharing PAC

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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