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

NCT07133321 | Enrolling By Invitation

• 1 other identifier: AMU-IUC-P3
• Study Type: interventional
• Target: 1,680
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maternal Health; Gender

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  8 months/37 weeks

Secondary Outcomes (3)

• Husband's involvement in maternal health

  8 months/37 weeks

• knowledge of obstetric danger signs and birth preparedness

  8 months/ 37 weeks

• Gender-equitable attitude

  8 months/ 37 weeks

Study Arms (4)

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.

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.

Behavioral: Helping Mothers Survive + RMC

Combined Intervention

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

no additional interventions beyond standard care.

Interventions

Husband Group Health education. 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.

Combined Intervention; Husband Group Education Only

Helping Mothers Survive + RMC 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; helping mother survive + RMC Training Only

Eligibility Criteria

• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Prof Yves Jacquemyn: lead
• Flemish Interuniversity Council (VLIR): collaborator
• Arba Minch University: collaborator

Study Sites (1)

Arba Minch university

Arba Minch, Southern Nations Nationalities Regional State, 21, Ethiopia

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Yves Jacquemyn, Professor, Gynecology

  Universiteit Antwerpen

  STUDY CHAIR

• Veerle Draulans, Professor, sociology

  KU Leuven

  STUDY CHAIR

• Jean-pierre vangeertruyden, Professor, infectious disesase

  Universiteit Antwerpen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 21, 2025
• Study Start: July 27, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

ET (1)