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

NCT ID: NCT01844024

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1010 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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misoprostol by midwife

Women with incomplete abortion is diagnosed and treated with misoprostol by midwife

Group Type OTHER

misoprostol by midwife

Intervention Type OTHER

Women with incomplete abortion is diagnosed and treated with misoprostol by midwife

Misoprostol by physician

Women with incomplete abortion is diagnosed and treated with misoprostol by physician

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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misoprostol by midwife

Women with incomplete abortion is diagnosed and treated with misoprostol by midwife

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Makerere University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Kristina Gemzell Danielsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josaphat Byamugisha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University

Locations

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Mulago Hospital

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.

Reference Type DERIVED
PMID: 34061352 (View on PubMed)

Cleeve A, Byamugisha J, Gemzell-Danielsson K, Mbona Tumwesigye N, Atuhairwe S, Faxelid E, Klingberg-Allvin M. Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda. PLoS One. 2016 Feb 12;11(2):e0149172. doi: 10.1371/journal.pone.0149172. eCollection 2016.

Reference Type DERIVED
PMID: 26872219 (View on PubMed)

Klingberg-Allvin M, Cleeve A, Atuhairwe S, Tumwesigye NM, Faxelid E, Byamugisha J, Gemzell-Danielsson K. Comparison of treatment of incomplete abortion with misoprostol by physicians and midwives at district level in Uganda: a randomised controlled equivalence trial. Lancet. 2015 Jun 13;385(9985):2392-8. doi: 10.1016/S0140-6736(14)61935-8. Epub 2015 Mar 27.

Reference Type DERIVED
PMID: 25817472 (View on PubMed)

Other Identifiers

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Tasksharing PAC

Identifier Type: -

Identifier Source: org_study_id