ClinicalTrials.gg
CompletedNCT02506413Updated Jul 9, 2020

Replicating MamaToto in Rural Tanzania

An interventional study of MamaToto Package in Maternal Death and Newborn Death, sponsored by University of Calgary. Completed at 1 site in Tanzania. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-09.

Sponsored by University of Calgary · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
8,323
Allocation
Not applicable
Ages
15 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Maternal Death
  • Newborn Death

Keywords

  • Maternal and Newborn Health
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In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 8,323 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Households with participants that are away for an extended time or have no one home at the time of survey completion
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8,323 participants (actual)

Study arms

  • Other
    MNCH Intervention Package

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

Interventions

  • OtherMamaToto Package

    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.

    Also known as: Mama na Mtoto

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Change between pre (baseline) and post (endline-up to 36 months) intervention

Secondary outcomes

  1. 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.

    Time frame: Change between pre (baseline) and post (endline-up to 36 months) intervention

  2. 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

    Time frame: Change between pre (baseline) and post (endline-up to 36 months) intervention

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Study locations

1 site
  • Catholic University of Health and Allied Sciences
    Mwanza, Tanzania
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References and documents

Publications

  • 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. PubMed 36369729 ↗

Individual participant data

Plan to share: Yes — De-Identified data will be shared with district officials, government offices and other stakeholders

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02506413
Collaborators
Catholic University of Health and Allied Sciences
Responsible party
Jennifer L. Brenner (Dr. Jennifer L. Brenner, University of Calgary) — Principal investigator
First posted
Jul 23, 2015
Start date
Apr 2016
Primary completion
Sep 2019
Completion
Mar 2020
Last update
Jul 9, 2020

Study contacts

Dismas K Matovelo, MD, MMed
principal investigator · Catholic University of Health and Allied Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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