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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844024
• Other study ID #: Tasksharing PAC
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2013
• Last updated: August 27, 2014
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Drug AuthorityUganda: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• misoprostol by midwife
Women with incomplete abortion is diagnosed and treated with misoprostol by midwife

Locations

Country	Name	City	State
Uganda	Mulago Hospital	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	contraceptive up take	Standardized questionnaires will be used to collect information about women's pre and post contraceptive uptake.	14 days	No
Primary	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	Yes
Secondary	bleeding	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	Yes
Secondary	pain	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	Yes
Secondary	acceptability	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	Yes
Secondary	un-scheduled visits	Standardized questionnaires will be used to collect information about women's time spent on travelling and on clinical visits following treatment.	14 days	Yes