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Enrolling by invitationNCT07133321Updated Aug 21, 2025

The Effectiveness of Multi-pronged Interventions to Improve Institutional Delivery in South Ethiopia

An interventional study of Husband Group Health education. and Helping Mothers Survive + RMC in Maternal Health and Gender, sponsored by Prof Yves Jacquemyn. Enrolling by invitation at 1 site in Ethiopia. Open to male participants. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by Prof Yves Jacquemyn · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
1,680
Allocation
Randomized
Sex
Male
01

Study 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.

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.

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.

  1. 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.

  2. 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

02

Conditions studied

  • Maternal Health
  • Gender

Keywords

  • Institutional delivery
  • postnatal care
  • Husband involvement
  • husband equitable gender norm
  • Respectful maternal care
  • helping mothers survive
03

In context

Lead sponsor

Prof Yves Jacquemyn is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
1,680 participants (estimated)

Study arms

  • Experimental
    Husband Group Education Only

    group sessions for husbands focused on birth preparedness, shared decision-making, and shared responsibility to support maternal health service utilization.

    Behavioral: Husband Group Health education.

  • Experimental
    helping mother survive + RMC Training Only

    training for health professionals to enhance skills in managing childbirth emergencies, making referrals, and providing culturally sensitive, woman-centered care.

    Behavioral: Helping Mothers Survive + RMC

  • Experimental
    Combined Intervention

    both husband education and helping mother survive + RMC Training implemented concurrently.

    Behavioral: Husband Group Health education. · Behavioral: Helping Mothers Survive + RMC

  • No intervention
    Control Group

    no additional interventions beyond standard care.

Interventions

  • BehavioralHusband 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.

  • BehavioralHelping Mothers Survive + RMC

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 months/ 37 weeks

  2. 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)

    Time frame: 8 months/37 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 months/37 weeks

  2. 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.

    Time frame: 8 months/ 37 weeks

  3. 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.

    Time frame: 8 months/ 37 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Apr 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2025
First posted
Aug 21, 2025
StartActual
Jul 27, 2025
Primary completionEst.
Apr 15, 2026
CompletionEst.
Apr 15, 2026
Last update
Aug 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07133321
Lead sponsor
Prof Yves Jacquemyn
Collaborators
Flemish Interuniversity Council (VLIR), Arba Minch University
Responsible party
Prof Yves Jacquemyn (Dr. Professor, Universiteit Antwerpen) — Sponsor-investigator
First posted
Aug 21, 2025
Start date
Jul 27, 2025
Primary completion
Apr 15, 2026 (estimated)
Completion
Apr 15, 2026 (estimated)
Last update
Aug 21, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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