Maternal Health CareNCT06451653
Men in Maternity Health (MiM) in Myanmar
A study testing Men in Maternity Health (MiM) Intervention in people with Maternal Health Care and Myanmar, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Health Care, Myanmar, Men in Maternity Health
- What is being tested?
- Men in Maternity Health (MiM) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteThailand
- Study dates
- 15 Oct 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Men in Maternity Health (MiM) Intervention on Male Involvement in Maternal Health Care to Improve Maternal Health Outcomes in Naypyitaw, Myanmar
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.
- Conditions
- Maternal Health Care, Myanmar, Men in Maternity Health, Male Partner, Institutional Delivery
- Being tested
- Men in Maternity Health (MiM) Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Men in Maternity Health (MiM) InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 months post-intervention
Secondary outcomes (1)
Institutional delivery
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.
Measured: Up to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start15 Oct 2018
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Health CareStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Myanmar Health Network Organization, Myanmar Maternal and Child Welfare Association
- Responsible party
- Principal investigator, May Chan Oo, Chulalongkorn University
- Investigators
- May Chan Oo, Principal investigator, College of Public Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451653
- Sponsor's protocol ID
- CUCPHS-001
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Men in Maternity Health (MiM) Intervention on Male Involvement in Maternal Health Care to Improve Maternal Health Outcomes in Naypyitaw, Myanmar
- ClinicalTrials.gov ID
- NCT06451653
- Acronym / sponsor ID
- CUCPHS-001
- Conditions
- Maternal Health Care, Myanmar, Men in Maternity Health, Male Partner, Institutional Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Myanmar Health Network Organization, Myanmar Maternal and Child Welfare Association
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men in Maternity Health (MiM) Intervention | Experimental | Behavioral: Men in Maternity Health (MiM) InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- For Men in Maternity Health (MiM) Intervention, male partners who
- Are severely ill and cannot communicate
- Do not give consent
- Feel uncomfortable to participate in this study
- Do not give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Men in Maternity Health (MiM) InterventionThe 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. | Behavioural | Men in Maternity Health (MiM) Intervention |
Primary outcome
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.
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.
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.
Acceptability and Feasibility of Men in Maternity Health (MiM) Intervention
Time frame: Up to 2 months post-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.
1 secondary outcome
Institutional delivery
Time frame: Up to 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Chan Oo principal investigator
College of Public Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Men in Maternity Health (MiM) Intervention in people with Maternal Health Care and Myanmar, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Health Knowledge (time frame: 2 months pre-intervention and 2 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.