Replicating MamaToto in Rural Tanzania
Primary Purpose
Maternal Death, Newborn Death
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
MamaToto Package
Sponsored by
About this trial
This is an interventional health services research trial for Maternal Death focused on measuring Maternal and Newborn Health
Eligibility 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
Sites / Locations
- Catholic University of Health and Allied Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MNCH Intervention Package
Arm Description
The division assigned to this arm received a comprehensive Maternal and Newborn Health (MNH) intervention package using the 'MamaToto Process'. Key intervention activities included: engaging district leaders in district health system strengthening; strengthening health facility-based MNH services; and establishing a Maternal, Newborn, and Child Health focused lay Community Health Worker program.
Outcomes
Primary Outcome Measures
Proportion of live births attended by a skilled health provider
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
Proportion of women receiving postnatal care <48H
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.
Proportion of women receiving antenatal care 4 or more times during pregnancy
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
Full Information
NCT ID
NCT02506413
First Posted
July 1, 2015
Last Updated
July 7, 2020
Sponsor
University of Calgary
Collaborators
Catholic University of Health and Allied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02506413
Brief Title
Replicating MamaToto in Rural Tanzania
Official Title
Replicating MamaToto in Rural Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Catholic University of Health and Allied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed 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 hypothesized 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.
Detailed Description
This study collected baseline data on indicators related to pre-natal care, delivery, post-natal care, treatment of childhood illnesses and family planning. Data collection tools/strategies included 1) a mapping exercise, 2) health facility audit 3) household surveys and 4) exit interviews. Data was collected at baseline and endline. Operational data was collected throughout the life of the study. Results were 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 was collected in two districts 1) Misungwi and 2) Kwimba. Baseline and endline data was collected in Misungwi only. The intervention began in Misungwi in Years 1 and 2 and then rolled out to Kwimba in Year 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Death, Newborn Death
Keywords
Maternal and Newborn Health
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study was part of a longitudinal implementation evaluation using an effectiveness-intervention hybrid (Type 2) design and a RE-AIM evaluation model.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MNCH Intervention Package
Arm Type
Other
Arm Description
The division assigned to this arm received a comprehensive Maternal and Newborn Health (MNH) intervention package using the 'MamaToto Process'. Key intervention activities included:
engaging district leaders in district health system strengthening;
strengthening health facility-based MNH services; and
establishing a Maternal, Newborn, and Child Health focused lay Community Health Worker program.
Intervention Type
Other
Intervention Name(s)
MamaToto Package
Other Intervention Name(s)
Mama na Mtoto
Intervention Description
The MamaToto Package (later called "Mama na Mtoto" for the Tanzanian context) was an MNCH intervention built upon prior successes in Uganda and adapted to meet the needs in Misungwi District in Tanzania. The intervention included low-cost programming that built 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 Measure Information:
Title
Proportion of live births attended by a skilled health provider
Description
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)
Time Frame
Change between pre (baseline) and post (endline-up to 36 months) intervention
Secondary Outcome Measure Information:
Title
Proportion of women receiving postnatal care <48H
Description
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.
Time Frame
Change between pre (baseline) and post (endline-up to 36 months) intervention
Title
Proportion of women receiving antenatal care 4 or more times during pregnancy
Description
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
Time Frame
Change between pre (baseline) and post (endline-up to 36 months) intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dismas K Matovelo, MD, MMed
Organizational Affiliation
Catholic University of Health and Allied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Health and Allied Sciences
City
Mwanza
Country
Tanzania
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-Identified data will be shared with district officials, government offices and other stakeholders
Citations:
PubMed Identifier
36369729
Citation
Matovelo D, Boniphace M, Singhal N, Nettel-Aguirre A, Kabakyenga J, Turyakira E, Mercader HFG, Khan S, Shaban G, Kyomuhangi T, Hobbs AJ, Manalili K, Subi L, Hatfield J, Ngallaba S, Brenner JL. Evaluation of a comprehensive maternal newborn health intervention in rural Tanzania: single-arm pre-post coverage survey results. Glob Health Action. 2022 Dec 31;15(1):2137281. doi: 10.1080/16549716.2022.2137281.
Results Reference
derived
Links:
URL
https://www.mnmtanzania.com/
Description
Mama na Mtoto website
Learn more about this trial
Replicating MamaToto in Rural Tanzania
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