Effect of Community Engagement Using M-Mama Champions

March 15, 2024 updated by: Alex Sanga, University of Dodoma

Effectiveness of Community Engagement Using M-Mama Champions in Improving Literacy of Obstetric Danger Signs, Birth Preparedness and Complication Readiness Among Pregnant Women in Bahi, Dodoma

This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be 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, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women in the first and second trimester (up to 28 weeks of GA).

Exclusion Criteria:

  • Pregnant women who will be sick and admitted,
  • Mentally incompetent, and
  • Those who won't consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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 Names:
  • Educational intervention
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women.
Time Frame: One month (4weeks)
Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on the awareness of the obstetric danger signs. It's anticipated that there will be a positive change in scores after the intervention.
One month (4weeks)
Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women
Time Frame: One month (4weeks)
Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on awareness of birth preparedness and complication readiness after the intervention. It's anticipated that the majority will be able to name at least three (3) of five (5) key elements of birth preparedness and complication readiness after the intervention.
One month (4weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness
Time Frame: One month (4weeks)
Change in the scores from a semi-structured interviewer-administered questionnaire on the reported practice of birth preparedness and complication readiness among pregnant women after the intervention.
One month (4weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dodoma

Collaborators

Stephen Kibusi
James Tumaini Kengia

Investigators

  • Study Director: James T Kengia, PhD, University of Dodoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Ref. No. MA.84/261/02/1/115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

2moths

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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