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Replicating MamaToto in Rural Tanzania

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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

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 23, 2015
Last Update Posted Date October 9, 2019
Study Start Date  ICMJE April 2016
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02506413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Replicating MamaToto in Rural Tanzania
Official Title  ICMJE Replicating MamaToto in Rural Tanzania
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Maternal Death
  • Newborn Death
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: MamaToto Package
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02506413
Other Study ID Numbers  ICMJE IRT #39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-Identified data will be shared with district officials, government offices and other stakeholders
Responsible Party Jennifer L. Brenner, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Catholic University of Health and Allied Sciences
Investigators  ICMJE
Principal Investigator: Dismas K Matovelo, MD, MMed Catholic University of Health and Allied Sciences
PRS Account University of Calgary
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP