Maternal DeathNCT02506413
Replicating MamaToto in Rural Tanzania
A study testing MamaToto Package in people with Maternal Death and Newborn Death, run by University of Calgary at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Death, Newborn Death
- What is being tested?
- MamaToto Package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,323 participants
- Where
- 1 siteTanzania
- Study dates
- Apr 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Households with participants that are away for an extended time or have no one home at the time of survey completion
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Maternal Death, Newborn Death
- Being tested
- MamaToto Package
- Keywords
- Maternal and Newborn Health
- Medical subject headings
- Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MamaToto PackageOther
Also called Mama na Mtoto
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MamaToto Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change between pre (baseline) and post (endline-up to 36 months) intervention
Secondary outcomes (2)
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.
Measured: Change between pre (baseline) and post (endline-up to 36 months) intervention
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
Measured: Change between pre (baseline) and post (endline-up to 36 months) intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startApr 2016
- Primary completionSep 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal DeathStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 8,323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of Health and Allied Sciences
- Responsible party
- Principal investigator, Jennifer L. Brenner, University of Calgary
- Investigators
- Dismas K Matovelo, MD, MMed, Principal investigator, Catholic University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506413
- Sponsor's protocol ID
- IRT #39
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2015
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-Identified data will be shared with district officials, government offices and other stakeholders
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replicating MamaToto in Rural Tanzania
- ClinicalTrials.gov ID
- NCT02506413
- Acronym / sponsor ID
- IRT #39
- Conditions
- Maternal Death, Newborn Death
- Keywords
- Maternal and Newborn Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,323 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Catholic University of Health and Allied Sciences
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| MNCH Intervention Package | Other | Other: MamaToto PackageThe 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Households with participants that are away for an extended time or have no one home at the time of survey completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MamaToto PackageAlso: Mama na MtotoThe 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. | Other | MNCH Intervention Package |
Primary outcome
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)
2 secondary outcomes
Proportion of women receiving postnatal care <48H
Time frame: Change between pre (baseline) and post (endline-up to 36 months) intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 36369729Matovelo 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.
- Mama na Mtoto websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-Identified data will be shared with district officials, government offices and other stakeholders
Related trials for Maternal Death
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruiting
Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
Maternal Health, Neonatal Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dismas K Matovelo, MD, MMed principal investigator
Catholic University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MamaToto Package in people with Maternal Death and Newborn Death, run by University of Calgary at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of live births attended by a skilled health provider (time frame: Change between pre (baseline) and post (endline-up to 36 months) intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.