NCT06451653

Brief Summary

World Health Organization integrated husband involvement into reproductive health programs to carry out safe motherhood successfully and therefore it has been encouraged as a new strategy to improve maternal health since 2000. In Myanmar, maternal health intervention and education programs for safe motherhood are progressing but maternal mortality is still high. Even though sufficient evidences prove that husband can influence maternal health care service utilization during pregnancy and there by positively impact obstetric emergency, few interventions have focused on husband directly to involve and also effectiveness of husband involvement intervention on birth preparedness and complication readiness for safe motherhood are still limited in Myanmar. Therefore, the objective of this study is to explore the effectiveness of the men in maternity health (MiM) intervention on male involvement in maternal health care, including its impact on knowledge about maternal health related issues, attitudes towards maternal health care and birth preparedness and complication readiness (BPCR) practices and improving institutional delivery rates for safe motherhood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

May 22, 2024

Last Update Submit

June 4, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Maternal Health Knowledge

    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

    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

    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

  • Acceptability and Feasibility of Men in Maternity Health (MiM) Intervention

    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.

    Up to 2 months post-intervention

Secondary Outcomes (1)

  • Institutional delivery

    Up to 3 months post-intervention

Study Arms (2)

Men in Maternity Health (MiM) Intervention

EXPERIMENTAL

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.

Behavioral: Men in Maternity Health (MiM) Intervention

Control

NO INTERVENTION

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.

Interventions

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.

Men in Maternity Health (MiM) Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

MenogarilMethods

Intervention Hierarchy (Ancestors)

NogalamycinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesInvestigative Techniques

Study Officials

  • May Chan Oo

    College of Public Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Researcher

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 11, 2024

Study Start

October 15, 2018

Primary Completion

August 30, 2019

Study Completion

September 30, 2019

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations