Effect of Community Engagement Using M-Mama Champions

Obstetric Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325319
• Other study ID #: Ref. No. MA.84/261/02/1/115
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: University of Dodoma
• Contact: Alex P Sanga, Msc. PH
• Phone: +255762144082
• Email: sanga.alex[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Complication
• Woman's Role

Intervention

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).

Locations

Country	Name	City	State
Tanzania	University of Dodoma	Dodoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Dodoma	James Tumaini Kengia, Stephen Kibusi

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women.	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)
Primary	Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women	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	Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness	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)