NCT02506413

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 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

July 1, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3.4 years

First QC Date

July 1, 2015

Last Update Submit

July 7, 2020

Conditions

Keywords

Maternal and Newborn Health

Outcome Measures

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)

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

Secondary Outcomes (2)

  • Proportion of women receiving postnatal care <48H

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

  • Proportion of women receiving antenatal care 4 or more times during pregnancy

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

Study Arms (1)

MNCH Intervention Package

OTHER

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

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
MNCH Intervention Package

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Health and Allied Sciences

Mwanza, Tanzania

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Maternal DeathPerinatal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dismas K Matovelo, MD, MMed

    Catholic University of Health and Allied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study was part of a longitudinal implementation evaluation using an effectiveness-intervention hybrid (Type 2) design and a RE-AIM evaluation model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jennifer L. Brenner

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 23, 2015

Study Start

April 1, 2016

Primary Completion

September 1, 2019

Study Completion

March 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

De-Identified data will be shared with district officials, government offices and other stakeholders

Locations