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

NCT01844024 | Completed Phase 4 DMC

• 1 other identifier: Tasksharing PAC
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Complete abortion

  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 Outcomes (4)

• bleeding

  14 days

• pain

  14 days

• acceptability

  14 days

• un-scheduled visits

  14 days

Other Outcomes (1)

• contraceptive up take

  14 days

Study Arms (2)

misoprostol by midwife

OTHER

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

Other: misoprostol by midwife

Misoprostol by physician

NO INTERVENTION

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

Interventions

misoprostol by midwife OTHER

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

misoprostol by midwife

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• bleeding and contractions during pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Makerere University: collaborator

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (3)

• 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.

  PMID: 34061352 DERIVED

• 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.

  PMID: 26872219 DERIVED

• 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.

  PMID: 25817472 DERIVED

Study Officials

• Josaphat Byamugisha, MD, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

UG (1)