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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-27

Study Completion Date

2026-04-15

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Maternal Health Gender

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Husband Group Education Only

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

Group Type EXPERIMENTAL

Husband Group Health education.

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Helping Mothers Survive + RMC

Intervention Type BEHAVIORAL

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.

Combined Intervention

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

Group Type EXPERIMENTAL

Husband Group Health education.

Intervention Type BEHAVIORAL

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 + RMC

Intervention Type BEHAVIORAL

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.

Control Group

no additional interventions beyond standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Helping 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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