- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06451653
Men in Maternity Health (MiM) in Myanmar
Effectiveness of Men in Maternity Health (MiM) Intervention on Male Involvement in Maternal Health Care to Improve Maternal Health Outcomes in Naypyitaw, Myanmar
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bangkok, Thailand, 10330
- Chulalongkorn University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
For Men in Maternity health (MiM) Intervention; male partners who
- Aged ≥ 18 years
- Partners' pregnancies are ≤16 weeks gestational age
- Partners are pregnant for the first time (Gravida 1)
- Currently live with their female partners
- Have been living in the study area for at least 1 year
For quantitative and qualitative assessment:
- Male partners who participated in the MiM intervention and their female partners
- Maternal health stakeholders who oversee MiM implementation and maternal health care providers in the intervention township
Exclusion criteria:
For Men in Maternity Health (MiM) Intervention, male partners who
- Are severely ill and cannot communicate
- Do not give consent
For quantitative and qualitative assessment:
- Feel uncomfortable to participate in this study
- Do not give consent
- Are severely ill and cannot communicate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Men in Maternity Health (MiM) Intervention
The men in maternity health (MiM) education program provided male partners of pregnant women with comprehensive education on maternal health, covering topics such as pregnancy complications, obstetric danger signs, maternal health care (including antenatal, delivery, and postnatal care), the benefits of birth preparedness and complication readiness (BPCR), and safe delivery practices.
Invitation letters were sent to male partners by public health supervisors every first and third week to encourage participation in the MiM program's activities, while maternal health education sessions were conducted every second and fourth week.
|
The six-month MiM education program focused on maternal health education for male partners of pregnant women in the intervention area.
Assigned midwives offered two-hour-long, face-to-face health education and discussion sessions at five selected health centres every second and fourth Sunday, respectively, to accommodate participants' work schedules.
Attendance consistently remained high at 80% of participants every month, with home visits for absentees to provide health education.
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No Intervention: Control
Male partners in the control group can only receive routine maternal health education if they accompany their female partners to antenatal care services at health facilities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Health Knowledge
Time Frame: 2 months pre-intervention and 2 months post-intervention
|
To assess the effectiveness of the Men in Maternity Health (MiM) intervention on male involvement in maternal health, specifically regarding changes in maternal health knowledge, including knowledge of maternal health care, danger signs during pregnancy, delivery, and the postpartum period. Measurement: Pre- and post-intervention surveys assessed knowledge with 12 questions, each containing multiple sub-questions. Scoring was '1' for each correct answer, with a total score range from 0 to 36. |
2 months pre-intervention and 2 months post-intervention
|
|
Attitudes Towards Maternal Health
Time Frame: 2 months pre-intervention and 2 months post-intervention
|
To assess the effectiveness of the Men in Maternity Health (MiM) intervention on male involvement in maternal health, specifically regarding changes in attitudes towards maternal health. Measurement: Pre- and post-intervention surveys assessed attitudes with 12 questions. For positive statements, scores ranged from 4 (strongly agree) to 1 (strongly disagree), and for negative statements, scores ranged from 1 (strongly disagree) to 4 (strongly agree), with a total score range of 12 to 48. |
2 months pre-intervention and 2 months post-intervention
|
|
Birth Preparedness and Complication Readiness (BPCR) Practices
Time Frame: 2 months pre-intervention and 2 months post-intervention
|
The impact of the Men in Maternity Health (MiM) intervention on male involvement in birth preparedness and complication readiness (BPCR) practices was assessed through pre- and post-intervention surveys.
BPCR practices include five key components: planning the health facility for birth, ensuring the presence of skilled birth attendants, arranging transportation for delivery or emergencies, identifying potential blood donors and saving money for delivery expenses.
BPCR practices were measured with a composite score derived from responses to five components, each corresponding to one of the essential BPCR practices.
Responses were scored '1' for 'Yes' and '0' for 'No'.
The total BPCR score ranged from 0 to 5, with higher scores indicating better birth preparedness and complication readiness.
|
2 months pre-intervention and 2 months post-intervention
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Acceptability and Feasibility of Men in Maternity Health (MiM) Intervention
Time Frame: Up to 2 months post-intervention
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To gain a comprehensive understanding of the impact of the MiM program, the acceptability and feasibility of the intervention were assessed through qualitative methods.
This included semi-structured interviews with maternal health stakeholders engaged in the MiM program and focus group discussions with male participants who involved in the MiM program and their partners.
Key areas explored included assessing the program's effectiveness in preventing maternal emergencies, promoting institutional deliveries and gathering participant satisfaction and feedback, and identifying the barriers and facilitators specific to the program's implementation.
Data were analyzed using thematic analysis to identify themes and patterns related to the intervention's acceptability and feasibility of the intervention, highlighting common experiences, challenges and facilitators reported by participants and healthcare stakeholders, as well as identifying perceived benefits of the intervention.
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Up to 2 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Institutional delivery
Time Frame: Up to 3 months post-intervention
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For institutional delivery outcomes, the place of delivery and the birth attendant for delivery were checked at the end of the study period through a post-intervention survey.
The researcher validated the reported institutional deliveries by cross-referencing birth certificate records and obtaining information from the assigned area midwives.
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Up to 3 months post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: May Chan Oo, College of Public Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CUCPHS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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