Child MortalityHCUMNCT01571765
MNCH Programming in Southwest Uganda Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA
A study testing MNCH programming in health district in people with Child Mortality and Maternal Mortality (All Cause), run by University of Calgary at 1 site in Uganda.
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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Mortality, Maternal Mortality (All Cause)
- What is being tested?
- MNCH programming in health district
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,985 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all households living in selected communities; all women 15-49 living in selected communities Exclusion Criteria: none
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaling Up Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA
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.
Read the 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.
- Conditions
- Child Mortality, Maternal Mortality (All Cause)
- Being tested
- MNCH programming in health district
- Keywords
- maternal, newborn, child
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MNCH programming in health district |
| no added MNCH activities | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced morbidity for children under five years old
Measured: 2 years
Secondary outcomes (1)
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MortalityStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian International Development Agency
- Responsible party
- Principal investigator, Jennifer L. Brenner, University of Calgary
- Investigators
- Jennifer Brenner, MD, Principal investigator, University of CalgaryJerome Kabakyenga, MBBS, PHD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571765
- Sponsor's protocol ID
- CIDA S-065346
- Acronym
- HCUM
- Status last verified
- May 2015
- First submitted
- 30 Mar 2012
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA
- ClinicalTrials.gov ID
- NCT01571765
- Acronym / sponsor ID
- HCUM / CIDA S-065346
- Conditions
- Child Mortality, Maternal Mortality (All Cause)
- Keywords
- maternal, newborn, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,985 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian International Development Agency
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNCH programming | Experimental | Other: MNCH programming in health districtprotocols 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 |
| no added MNCH activities | No intervention | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all households living in selected communities; all women 15-49 living in selected communities Exclusion Criteria: none
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNCH programming in health districttraining 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 | Other | MNCH programming |
Primary outcome
Reduced morbidity for children under five years old
Time frame: 2 years
1 secondary outcome
improved maternal access to health services
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Brenner, MD principal investigator
University of Calgary
Jerome Kabakyenga, MBBS, PHD principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNCH programming in health district in people with Child Mortality and Maternal Mortality (All Cause), run by University of Calgary at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced morbidity for children under five years old (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.