Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2024-03-31
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The following is the hypothesis being tested
Null Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches.
Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches.
During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention.
The control arm won't receive any intervention.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Trained Religious Leaders' Engagement in Maternal Health Education in Ethiopia
NCT05716178
Healthy Baby Healthy Mother Toolkit
NCT06594419
Essential Coaching for Every Mother in Tanzania
NCT05362305
Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
NCT02882607
Chamas for Change Validation
NCT03187873
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Maternal mortality remains a global public health issue, Sustainable Development Goal (SDG) 3 targets to reduce it to less than 70 for every 100,000 live births by 2030 globally. Maternal mortality whose peak is during intrapartum and the first day post-partum, 75% of it is accounted for by obstetric danger signs complications. Tanzania's maternal mortality ratio stands at 104 for every 100,000 live births, higher than the SDG target. Innovations that include women groups like M-MAMA Champions are necessary to improve the literacy level of obstetric danger signs, birth preparedness, and complication readiness among pregnant women and enhance obstetric emergency response and service utilization, for essential interventions in healthcare facilities alone haven't been able to reduce maternal mortality due to poor services utilization.
Methods and analysis:
A community-based, cluster randomized controlled trial (cRCT) design, will be utilized in undertaking the study of 120 first and second-trimester pregnant women randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, each two-hour session delivered in two weeks, using participatory learning and action model for women groups. The effect of the intervention will be determined using repeated ANOVA analysis.
Ethics and dissemination. The University of Dodoma Research Ethics Committee approved this study (Ref. No. MA.84/261/02/1/115). The study will ensure the protection of the participants' values, dignity, and integrity by the Helsinki Declaration by the World Medical Association. The study results will be published in peer-reviewed journals and disseminated at various conferences, and the government through the Ministry of Health.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
M-MAMA Champions group
Those study participants randomized to the intervention arm will receive the intervention being tested in this study. The intervention will be community engagement through the M-MAMA Champions on obstetric danger signs, birth preparedness, and complication readiness, whereby sensitization to pregnant women will be done. The sensitization package will be delivered by M-MAMA Champions and will encompass obstetric danger signs, birth preparedness, and complication readiness that will be adapted from the Ministry of Health, Tanzania. The package is being used to empower Community Health Workers (CHWs). The intervention is expected to be delivered in two (2) wards (4 Clusters) to be selected in Bahi Council, Dodoma for a period of one month from March to April 2024 and raise awareness by at least 20% in the intervention arm within a study period.
Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women
Community engagement using M-MAMA Champions to improve awareness of obstetric danger signs, birth preparedness, and complication readiness among pregnant women. The empowered M-MAMA Champions will deliver the intervention to pregnant women in their communities. A total of three (3) sessions will be held, whereby each will take two (2) hours. The sensitization will take place at one of the study participant's residential area, where women will gather up and be sensitized on the subject by the M-MAMA Champion as a facilitator using a well-prepared brochure (package).
Routine service group
The study participants who will be randomized to the control arm won't receive the intervention, instead, they will continue receiving the routine services. The routine services for pregnant women specifically on knowledge-related empowerment include the package delivered by the healthcare workers at the reproductive and child health clinics. The package is delivered during every Ante Natal Care (ANC) visit to the pregnant woman. The package contains basic information that is also tailored to the specific needs of pregnant women and is delivered with much emphasis to those who are prone to experience pregnancy-related complications for instance, those with Bad Obstetric History (BOH), cardiovascular diseases, or diabetics. The control groups are expected to be derived from two (2) wards (4 Clusters) to be selected in Bahi Council, Dodoma
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women
Community engagement using M-MAMA Champions to improve awareness of obstetric danger signs, birth preparedness, and complication readiness among pregnant women. The empowered M-MAMA Champions will deliver the intervention to pregnant women in their communities. A total of three (3) sessions will be held, whereby each will take two (2) hours. The sensitization will take place at one of the study participant's residential area, where women will gather up and be sensitized on the subject by the M-MAMA Champion as a facilitator using a well-prepared brochure (package).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Mentally incompetent, and
* Those who won't consent to participate in the study.
15 Years
49 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stephen Kibusi
UNKNOWN
James Tumaini Kengia
UNKNOWN
University of Dodoma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alex Sanga
Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James T Kengia, PhD
Role: STUDY_DIRECTOR
University of Dodoma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Dodoma
Dodoma, , Tanzania
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Sanga A, Kibusi S, Kengia JT. The effectiveness of community engagement using M-Mama champions in improving awareness of obstetric danger signs, birth preparedness and complication readiness among pregnant women in Bahi, Dodoma: A cluster randomized pragmatic implementation trial. PLOS Glob Public Health. 2025 Apr 8;5(4):e0004315. doi: 10.1371/journal.pgph.0004315. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ref. No. MA.84/261/02/1/115
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.