NCT01571765

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,985

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

March 30, 2012

Last Update Submit

May 4, 2015

Conditions

Child MortalityMaternal Mortality (All Cause)

Keywords

maternalnewbornchild

Outcome Measures

Primary Outcomes (1)

  • Reduced morbidity for children under five years old

    2 years

Secondary Outcomes (1)

  • improved maternal access to health services

    24 months

Study Arms (2)

MNCH programming

EXPERIMENTAL

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

no added MNCH activities

NO INTERVENTION

Interventions

MNCH programming in health districtOTHER

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

MNCH programming

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Mbarara, Uganda

Location

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Brenner, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Jerome Kabakyenga, MBBS, PHD

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

UG(1)