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MNCH Programming in Southwest Uganda Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA (HCUM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Calgary
Sponsor:
Collaborator:
Canadian International Development Agency
Information provided by (Responsible Party):
Jennifer L. Brenner, University of Calgary
ClinicalTrials.gov Identifier:
NCT01571765
First received: March 30, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Child Mortality
Maternal Mortality (All Cause)
Other: MNCH programming in health district

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Scaling Up Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Reduced morbidity for children under five years old [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved maternal access to health services [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 3000
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MNCH programming
protocols and training for data collection, referrals, and management for health district. Training in obstetrics, newborn care and management of sick children for health workers, Increased community health promotion such as training of CHWs, health centre management teams and bednet distribution
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
No Intervention: no added MNCH activities

Detailed 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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all households living in selected communities; all women 15-49 living in selected communities Exclusion Criteria: none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571765

Contacts
Contact: jennifer Brenner, MD, FRCPC 4039552462 jennbrenner@me.com
Contact: jerome kabakyenga, MBBS, PhD jkabakyenga@gmail.com

Locations
Uganda
Mbarara University of Science and Technology Recruiting
Mbarara, Uganda
Contact: Eleanor Turyakira, MSc       eleanor.tk@gmail.com   
Sponsors and Collaborators
University of Calgary
Canadian International Development Agency
Investigators
Principal Investigator: jennifer Brenner, MD University of Calgary
Principal Investigator: jerome kabakyenga, MBBS, PHD Mbarara University of Science and Technology
  More Information

No publications provided

Responsible Party: Jennifer L. Brenner, Clinical Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01571765     History of Changes
Other Study ID Numbers: CIDA S-065346
Study First Received: March 30, 2012
Last Updated: July 14, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
maternal
newborn
child

Additional relevant MeSH terms:
Maternal Death
Death
Parental Death
Pathologic Processes
Pregnancy Complications

ClinicalTrials.gov processed this record on November 25, 2014