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Replicating MamaToto in Rural Tanzania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02506413
Recruitment Status : Active, not recruiting
First Posted : July 23, 2015
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Catholic University of Health and Allied Sciences
Information provided by (Responsible Party):
Jennifer L. Brenner, University of Calgary

Brief Summary:
This study aims to adapt and implement a district-led, policy-based, low cost Maternal and Newborn Health (MNH) intervention package using the MamaToto process, proven successful in Uganda, in rural Tanzania. The investigators hypothesize that the 'MamaToto Package' will be successfully implemented in the Misungwi District and will be effective in improving key maternal and newborn health indicators of study participants.

Condition or disease Intervention/treatment Phase
Maternal Death Newborn Death Other: MamaToto Package Not Applicable

Detailed Description:

This study will collect baseline data on indicators related to pre-natal care, delivery, post-natal care, treatment of childhood illnesses and family planning. Data collection tools/strategies include 1) a mapping exercise, 2) health facility audit 3) household surveys and 4) exit interviews. Data will be collected at baseline and endline. Operational data will be collected throughout the life of the study. Results will be used to inform implementation of interventions that aim to improve health facility capacity to deliver good quality care to women and children and to strengthen families and communities to better advocate for and engage in activities that promote healthier women and children.

Mapping data will be collected in two districts 1) Misungwi and 2) Kwimba. Baseline and endline data will be collected in Misungwi The intervention will begin in Misungwi in Yrs 1 and 2 and then roll out to Kwimba in YR 3.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Replicating MamaToto in Rural Tanzania
Study Start Date : April 2016
Actual Primary Completion Date : September 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
MNCH Intervention Package

The division assigned to this arm will receive a comprehensive Maternal and Newborn Health (MNH) intervention package using the 'MamaToto Process'. Key intervention activities include:

  1. engaging district leaders in district health system strengthening;
  2. strengthening health facility-based MNH services; and
  3. establishing a Maternal, Newborn, and Child Health focused lay Community Health Worker program.
Other: MamaToto Package
The MamaToto Package is an MNCH intervention that builds upon a prior successes in Uganda and will be adapted to meet the needs in Misungwi District in Tanzania. The intervention includes low-cost programming that builds upon the existing district health system structure and resources in order to strengthen the MNH capacity and training of the district, health facilities, and community health workers.




Primary Outcome Measures :
  1. Proportion of live births attended by a skilled health provider [ Time Frame: Change between pre (baseline) and post (endline-up to 36 months) intervention ]
    Percentage of women (15-49 year old) with at least one recent live birth (past two years) reporting their last delivery being attended to by a skilled health personnel (doctor, nurse, midwife, clinical officer or auxiliary midwife)


Secondary Outcome Measures :
  1. Proportion of women receiving postnatal care <48H [ Time Frame: Change between pre (baseline) and post (endline-up to 36 months) intervention ]
    Percentage of women (15-49 years old) with a recent birth (<2 years) reporting postnatal care by any provider for within 2 days (0-48 hours) after her most recent delivery.

  2. Proportion of women receiving antenatal care 4 or more times during pregnancy [ Time Frame: Change between pre (baseline) and post (endline-up to 36 months) intervention ]
    Percentage of women (15-49 years old) reporting four or more antenatal care visits at a health facility during their most pregnancy, where their last pregnancy was completed within two years of survey



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Randomly selected households (30) living in selected hamlets with a competent participant of greater than 15 years of age
  • All women of reproductive age (age 15-49 years old) living in selected households in selected hamlets

Exclusion Criteria:

  • Households with participants that are away for an extended time or have no one home at the time of survey completion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506413


Locations
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Tanzania
Catholic University of Health and Allied Sciences
Mwanza, Tanzania
Sponsors and Collaborators
University of Calgary
Catholic University of Health and Allied Sciences
Investigators
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Principal Investigator: Dismas K Matovelo, MD, MMed Catholic University of Health and Allied Sciences

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Responsible Party: Jennifer L. Brenner, Dr. Jennifer L. Brenner, University of Calgary
ClinicalTrials.gov Identifier: NCT02506413     History of Changes
Other Study ID Numbers: IRT #39
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-Identified data will be shared with district officials, government offices and other stakeholders

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer L. Brenner, University of Calgary:
Maternal and Newborn Health
Additional relevant MeSH terms:
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Maternal Death
Death
Pathologic Processes
Pregnancy Complications
Parental Death