Effect of Community Engagement Using M-Mama Champions

Not Applicable

Not yet recruiting

• Conditions: Obstetric Complication; Woman's Role
• Interventions: Other: Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women

• Registration Number: NCT06325319
• Lead Sponsor: University of Dodoma

Brief Summary

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.

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 Timeline

• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M-MAMA Champions group	Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women	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.

Primary Outcome Measures

Name	Time	Method
Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women.	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.
Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness	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.

Trial Locations

Locations (1)

University of Dodoma; 🇹🇿 Dodoma, Tanzania