Maternal HealthNCT07133321
The Effectiveness of Multi-pronged Interventions to Improve Institutional Delivery in South Ethiopia
A study testing Husband Group Health education. and Helping Mothers Survive + RMC in people with Maternal Health and Gender, run by Prof Yves Jacquemyn at 1 site in Ethiopia.
Trial summary
This study aims to improve the health and safety of mothers during pregnancy and childbirth by working closely with their husbands. In many communities in Ethiopia, husbands play an important role in decisions about where women give birth. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Maternal Health, Gender
- What is being tested?
- Husband Group Health education. and Helping Mothers Survive + RMC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- 1 siteEthiopia
- Study dates
- 27 Jul 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A husband whose wife is under 27 weeks of gestation
- A husband whose wife had a previous baby within 5 years
- A husband who lives with his wife together
- A husband who has lived with his wife in the selected cluster for at least six months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site
Arba Minch university
Arba Minch, Southern Nations Nationalities Regional State, 21
About this study
This study aims to improve the health and safety of mothers during pregnancy and childbirth by working closely with their husbands. In many communities in Ethiopia, husbands play an important role in decisions about where women give birth.
The study involves educating husbands in group sessions to help them understand how to support their wives during pregnancy, prepare for childbirth, recognize danger signs, and encourage giving birth in health centers where skilled care is available.
Read more
At the same time, some health workers receive training to improve their ability to handle childbirth emergencies and provide respectful, culturally sensitive care.
Communities are divided into groups that receive either husband education, health worker training, both, or no additional support. The study will see which approach helps more women deliver safely in health centers and receive care after birth.
By involving husbands and improving health worker skills, this study hopes to support mothers better and improve outcomes for families.
Read the detailed description
This study is conducted in Southern Ethiopia to improve the utilization of maternal health services, helping more women access safe childbirth and postnatal care. Many women face challenges in using health facilities for delivery, which can increase risks for mothers and babies. The study tests two key interventions that support mothers by involving both their families and health workers.
- Husband Group Education: Since husbands often influence decisions about childbirth, this intervention provides group education sessions for husbands. These sessions focus on: Supporting their wives during pregnancy and childbirth. Preparing for birth and recognizing danger signs. Encouraging facility-based delivery where skilled care is available. Promoting shared decision-making and responsibility sharing between husbands and wives around pregnancy and childbirth. By increasing husbands' knowledge and encouraging joint responsibility, the study aims to improve the use of maternal health services by women.
- Health Worker Training on Helping mother survive integrated RMC:
This intervention improves health workers' skills at local health facilities in Southern Ethiopia to:
Manage common childbirth emergencies.
Provide timely referrals and emergency care.
Deliver culturally sensitive and woman-centered care.
Enhance overall quality of care, making health facilities more effective and trusted.
The study uses a cluster randomized controlled trial design with four groups to compare the effects of these interventions:
Husband group education only,
Health worker training only,
Both husband education and health worker training,
No intervention (control group).
The primary goal is to identify which intervention best increases the number of women who give birth at health facilities and receive postnatal care. Secondary goals include improving husbands' knowledge and attitudes about birth preparedness, gender roles, and shared responsibilities, as well as enhancing health workers' knowledge and skills.
Overall, this study seeks to find effective ways to increase maternal health service utilization by fostering husband involvement and strengthening health system readiness, contributing to safer childbirth and healthier families in Southern Ethiopia
- Conditions
- Maternal Health, Gender
- Being tested
- Husband Group Health education., Helping Mothers Survive + RMC
- Keywords
- Institutional delivery, postnatal care, Husband involvement, husband equitable gender norm, Respectful maternal care, helping mothers survive
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Husband Group Health education.Behavioural
The community-based husband group health education will target expectant fathers with pregnant partners. It will focus on reshaping gender-related attitudes and beliefs, promoting caregiving best practices, preventing violence against women, and improving men's involvement in maternal health. The intervention will comprise group sessions with 20 participants each, conducted over three sessions lasting 2.5 hours each, with a 15-day interval between sessions. The sessions will cover key topics, including recognizing obstetric danger signs, preparing for childbirth, fostering men's engagement in maternal health, advocating nonviolence and shared responsibility, and encouraging joint decision-making.
Helping Mothers Survive + RMCBehavioural
The "Helping Mothers Survive" training is designed by Jhpiego, an affiliate of Johns Hopkins University, in collaboration with global health partners, including the World Health Organization (WHO), Laerdal Global Health, and the International Confederation of Midwives (ICM) for healthcare professionals involved in childbirth care focusing on saving lives at birth in low-resource settings. This on-site training will use realistic simulations to enhance skills in identifying and managing key causes of maternal mortality, such as postpartum hemorrhage and preeclampsia, starting with essential labor care. The program employs the MamaNatalie birthing simulator, a low-tech realistic tool for hands-on practice developed by Laerdal Global Health. MamaNatalie features a model uterus with a neonate, placenta, and umbilical cord, enabling simulations of postpartum hemorrhage, breech delivery, vacuum-assisted birth, and normal labor.
| Study group | Role | What they receive |
|---|---|---|
| Husband Group Education Only | Experimental | group sessions for husbands focused on birth preparedness, shared decision-making, and shared responsibility to support maternal health service utilization. Receives: Behavioral: Husband Group Health education. |
| helping mother survive + RMC Training Only | Experimental | training for health professionals to enhance skills in managing childbirth emergencies, making referrals, and providing culturally sensitive, woman-centered care. Receives: Behavioral: Helping Mothers Survive + RMC |
| Combined Intervention | Experimental | both husband education and helping mother survive + RMC Training implemented concurrently. Receives: Behavioral: Husband Group Health education.; Behavioral: Helping Mothers Survive + RMC |
| Control Group | No intervention | no additional interventions beyond standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
institutional delivery
Proportion of women who delivered in a health facility, institutional delivery refers to childbirth in a health facility, such as a hospital or health center, where skilled birth attendants are available to manage normal deliveries and handle complications that may occur
Measured: 8 months/ 37 weeks
Maternal postnatal care
Proportion of mothers receiving at least one postnatal care visit within 6 weeks postpartum. The care given to the mother right after delivery and during the six weeks following childbirth (having at least one maternal postpartum care within six weeks of delivery)
Measured: 8 months/37 weeks
Secondary outcomes (3)
Husband's involvement in maternal health
Husband involvement was measured using the 21-item structured questionnaire adapted from the Global Framework for Assessing Male Participation in Maternal Health (Delphi method). Total scores range from 0 to 21. The mean score will be reported, and husbands will also be classified into three categories: low, moderate, and high involvement based on the sample distribution.
Measured: 8 months/37 weeks
knowledge of obstetric danger signs and birth preparedness
Proportion that knew the danger signs of pregnancy, childbirth and postpartum period. Knowledge of obstetric danger signs includes identifying complications that may arise during pregnancy, labor and childbirth, and the postpartum period. Similarly, knowledge of birth preparedness involves knowing the planning for key aspects of safe delivery, such as arranging transportation, saving money, identifying blood donors, selecting a skilled provider, Identifying the place of delivery, Identifying someone to provide support, and preparing essential supplies like clean sheets, baby clothes, and sanitary items. Husbands who correctly listed at least three danger signs will be classified as having good awareness, while those who listed fewer than three will be classified as having poor awareness.
Measured: 8 months/ 37 weeks
Gender-equitable attitude
Assesses attitudes toward gender norms, particularly in areas such as relationships, domestic responsibilities, reproductive health, and gender-based violence. For each participant, responses to the GEM scales were added together to form composite discrete variables that were categorized into high inequity = 24-39, Moderate inequity = 40-55, and low inequity = 56-72. Participants responded: Totally Agree =1; Partially Agree =2, or Do Not Agree=3 for each of the items of GEM scale Score.
Measured: 8 months/ 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start27 Jul 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is a cluster randomized controlled trial conducted in Southern Ethiopia. Clusters (communities) are randomly assigned to one of four parallel arms: (1) husband group education only, (2) health worker helping mother survive + RMC training only, (3) both husband education and health worker training combined, or (4) control group receiving standard care. The husband education focuses on increasing knowledge and involvement in birth preparedness, shared decision-making, and responsibility sharing. The health worker training enhances skills in managing childbirth emergencies and providing culturally sensitive and respectful care. Randomization is done at the cluster level to avoid contamination. The study is open-label without masking due to the nature of interventions. The primary aim is to evaluate the effect of these interventions on improving maternal health service utilization, including institutional delivery and postpartum care.
- Masking
- None (open label)
- Enrolment
- 1,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Yves Jacquemyn
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Responsible party
- Sponsor-investigator, Prof Yves Jacquemyn, Universiteit Antwerpen
- Investigators
- Yves Jacquemyn, Professor, Gynecology, Study chair, Universiteit AntwerpenVeerle Draulans, Professor, sociology, Study chair, KU LeuvenJean-pierre vangeertruyden, Professor, infectious disesase, Study chair, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133321
- Sponsor's protocol ID
- AMU-IUC-P3
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Multi-pronged Interventions to Improve Institutional Delivery in South Ethiopia
- ClinicalTrials.gov ID
- NCT07133321
- Acronym / sponsor ID
- AMU-IUC-P3
- Conditions
- Maternal Health, Gender
- Keywords
- Institutional delivery, postnatal care, Husband involvement, husband equitable gender norm, Respectful maternal care, helping mothers survive
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,680 participants (estimated)
- Lead sponsor
- Prof Yves JacquemynUniversity, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 21 Aug 2025 (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.
This study aims to improve the health and safety of mothers during pregnancy and childbirth by working closely with their husbands. In many communities in Ethiopia, husbands play an important role in decisions about where women give birth.
The study involves educating husbands in group sessions to help them understand how to support their wives during pregnancy, prepare for childbirth, recognize danger signs, and encourage giving birth in health centers where skilled care is available.
At the same time, some health workers receive training to improve their ability to handle childbirth emergencies and provide respectful, culturally sensitive care.
Communities are divided into groups that receive either husband education, health worker training, both, or no additional support. The study will see which approach helps more women deliver safely in health centers and receive care after birth.
By involving husbands and improving health worker skills, this study hopes to support mothers better and improve outcomes for families.
Detailed description
This study is conducted in Southern Ethiopia to improve the utilization of maternal health services, helping more women access safe childbirth and postnatal care. Many women face challenges in using health facilities for delivery, which can increase risks for mothers and babies. The study tests two key interventions that support mothers by involving both their families and health workers.
- Husband Group Education: Since husbands often influence decisions about childbirth, this intervention provides group education sessions for husbands. These sessions focus on: Supporting their wives during pregnancy and childbirth. Preparing for birth and recognizing danger signs. Encouraging facility-based delivery where skilled care is available. Promoting shared decision-making and responsibility sharing between husbands and wives around pregnancy and childbirth. By increasing husbands' knowledge and encouraging joint responsibility, the study aims to improve the use of maternal health services by women.
- Health Worker Training on Helping mother survive integrated RMC:
This intervention improves health workers' skills at local health facilities in Southern Ethiopia to:
Manage common childbirth emergencies.
Provide timely referrals and emergency care.
Deliver culturally sensitive and woman-centered care.
Enhance overall quality of care, making health facilities more effective and trusted.
The study uses a cluster randomized controlled trial design with four groups to compare the effects of these interventions:
Husband group education only,
Health worker training only,
Both husband education and health worker training,
No intervention (control group).
The primary goal is to identify which intervention best increases the number of women who give birth at health facilities and receive postnatal care. Secondary goals include improving husbands' knowledge and attitudes about birth preparedness, gender roles, and shared responsibilities, as well as enhancing health workers' knowledge and skills.
Overall, this study seeks to find effective ways to increase maternal health service utilization by fostering husband involvement and strengthening health system readiness, contributing to safer childbirth and healthier families in Southern Ethiopia
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a cluster randomized controlled trial conducted in Southern Ethiopia. Clusters (communities) are randomly assigned to one of four parallel arms: (1) husband group education only, (2) health worker helping mother survive + RMC training only, (3) both husband education and health worker training combined, or (4) control group receiving standard care. The husband education focuses on increasing knowledge and involvement in birth preparedness, shared decision-making, and responsibility sharing. The health worker training enhances skills in managing childbirth emergencies and providing culturally sensitive and respectful care. Randomization is done at the cluster level to avoid contamination. The study is open-label without masking due to the nature of interventions. The primary aim is to evaluate the effect of these interventions on improving maternal health service utilization, including institutional delivery and postpartum care.
| Arm | Type | Receives |
|---|---|---|
| Husband Group Education Only | Experimental | Behavioral: Husband Group Health education.group sessions for husbands focused on birth preparedness, shared decision-making, and shared responsibility to support maternal health service utilization. |
| helping mother survive + RMC Training Only | Experimental | Behavioral: Helping Mothers Survive + RMCtraining for health professionals to enhance skills in managing childbirth emergencies, making referrals, and providing culturally sensitive, woman-centered care. |
| Combined Intervention | Experimental | Behavioral: Husband Group Health education., Behavioral: Helping Mothers Survive + RMCboth husband education and helping mother survive + RMC Training implemented concurrently. |
| Control Group | No intervention | –no additional interventions beyond standard care. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A husband whose wife is under 27 weeks of gestation
- A husband whose wife had a previous baby within 5 years
- A husband who lives with his wife together
- A husband who has lived with his wife in the selected cluster for at least six months
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Husband Group Health education.The community-based husband group health education will target expectant fathers with pregnant partners. It will focus on reshaping gender-related attitudes and beliefs, promoting caregiving best practices, preventing violence against women, and improving men's involvement in maternal health. The intervention will comprise group sessions with 20 participants each, conducted over three sessions lasting 2.5 hours each, with a 15-day interval between sessions. The sessions will cover key topics, including recognizing obstetric danger signs, preparing for childbirth, fostering men's engagement in maternal health, advocating nonviolence and shared responsibility, and encouraging joint decision-making. | Behavioural | Combined Intervention, Husband Group Education Only |
| Helping Mothers Survive + RMCThe "Helping Mothers Survive" training is designed by Jhpiego, an affiliate of Johns Hopkins University, in collaboration with global health partners, including the World Health Organization (WHO), Laerdal Global Health, and the International Confederation of Midwives (ICM) for healthcare professionals involved in childbirth care focusing on saving lives at birth in low-resource settings. This on-site training will use realistic simulations to enhance skills in identifying and managing key causes of maternal mortality, such as postpartum hemorrhage and preeclampsia, starting with essential labor care. The program employs the MamaNatalie birthing simulator, a low-tech realistic tool for hands-on practice developed by Laerdal Global Health. MamaNatalie features a model uterus with a neonate, placenta, and umbilical cord, enabling simulations of postpartum hemorrhage, breech delivery, vacuum-assisted birth, and normal labor. | Behavioural | Combined Intervention, helping mother survive + RMC Training Only |
Primary outcome
institutional delivery
Time frame: 8 months/ 37 weeks
Proportion of women who delivered in a health facility, institutional delivery refers to childbirth in a health facility, such as a hospital or health center, where skilled birth attendants are available to manage normal deliveries and handle complications that may occur
Maternal postnatal care
Time frame: 8 months/37 weeks
Proportion of mothers receiving at least one postnatal care visit within 6 weeks postpartum. The care given to the mother right after delivery and during the six weeks following childbirth (having at least one maternal postpartum care within six weeks of delivery)
3 secondary outcomes
Husband's involvement in maternal health
Time frame: 8 months/37 weeks
knowledge of obstetric danger signs and birth preparedness
Time frame: 8 months/ 37 weeks
Gender-equitable attitude
Time frame: 8 months/ 37 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- 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.
Yves Jacquemyn, Professor, Gynecology study chair
Universiteit Antwerpen
Veerle Draulans, Professor, sociology study chair
KU Leuven
Jean-pierre vangeertruyden, Professor, infectious disesase study chair
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Husband Group Health education. and Helping Mothers Survive + RMC in people with Maternal Health and Gender, run by Prof Yves Jacquemyn at 1 site in Ethiopia.
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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 21 Aug 2025. 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 Ethiopia. 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?
This study is still under way. Results are not available in the source record yet.
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?
institutional delivery (time frame: 8 months/ 37 weeks). The study lists 2 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 21 Aug 2025.