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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571765
Other study ID # CIDA S-065346
Secondary ID
Status Completed
Phase N/A
First received March 30, 2012
Last updated May 4, 2015
Start date April 2012
Est. completion date March 2015

Study information

Verified date May 2015
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The investigators will assess whether in Bushenyi District in southwestern Uganda, a two year intervention providing comprehensive MNCH programming will:

- Reduce morbidity and mortality for children under five years old and;

- Improve access to maternal health services Compared to a control community without MNCH intervention?

Hypothesis:

Comprehensive maternal, newborn and child health programming in Bushenyi Distrcit can have a positive impact on morbidity and mortality for children under five years and will improve access for women to maternal health services which may lead, in the longer term, to decreased maternal mortality.


Description:

A detailed impact assessment will be carried out for the duration of the MNCH training and support initiative in Bushenyi District, using mixed methods. The study will assess 8 of the 11 key core MNCH indicators as identified by CIDA as a priority. Other information to be collected such as demographics and patterns of health care use, and prevalence of disease will help health planners in the districts, and will be helpful in sub analysis and interpretation of findings. The main study will use household surveys in both districts at baseline, midline and endline. Other tools will include pre and post qualitative surveys (FGDs, KII) and analysis of operational data.

The main study group will be representative communities and health centres within Bushenyi District who will receive intervention between 2012 and 2014; Rubirizi District will serve as a control area for this study but will received selected MNCH services starting in 2013 after midline data are collected.


Recruitment information / eligibility

Status Completed
Enrollment 10985
Est. completion date March 2015
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- all households living in selected communities; all women 15-49 living in selected communities Exclusion Criteria: none

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Other:
MNCH programming in health district
training at health district level in management, data collection. Training at health centres in obstetrics and pediatrics and training in community of CHWs and bednet distribution

Locations

Country Name City State
Uganda Mbarara University of Science and Technology Mbarara

Sponsors (2)

Lead Sponsor Collaborator
University of Calgary Canadian International Development Agency

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduced morbidity for children under five years old 2 years No
Secondary improved maternal access to health services proportion of pregnant women who have attended antenatal care four or more times; proportion of women whose most recent delivery was attended by a skilled birth attendant; met need for contraception (CIDA indicator) 24 months No
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