Effectiveness of Health Education Provided to Couples on Utilization of Maternity Waiting Homes in Rural Ethiopia

Effectiveness of Health Education Provided to Couples on Knowledge, Attitude, and Utilization of Maternity Waiting Homes in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial

Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal & neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. It is important to investigate what strategies could be effective in improving MWH utilization. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of male partner involvement intervention on MWH utilization in Ethiopia.

Study Overview

• Status: Recruiting
• Conditions: Maternal Behavior; Maternal Death
• Intervention / Treatment: Behavioral: Behavioral intervention

Detailed Description

The primary cause of adverse maternal health outcomes has been identified to be the delay in reaching care. This is often attributed to the long distances women need to travel to gain access to health facilities. Literature shows that maternity waiting homes contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal and neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. So, it is important to investigate what strategies could be effective in improving MWH utilization in Ethiopia.

The aim of this study is to evaluate the effect of male partner involvement intervention on MWH utilization in Hadiya Zone, Southern Ethiopia. A cluster-randomized controlled trial will be performed. The intervention will have two arms, i.e., intervention and control. It will be a behavioral intervention. The interventions will be health education, home visit, and the provision of Information Education Communication (IEC) materials/leaflets. Health education will be delivered to "husband-expectant wife" pairs at the baseline. Then home visits will be conducted two times (in the third and fifth months of the intervention period). Leaflets will be provided to the study participants three times, i.e., at the baseline and during every home visit. The study participants will be pregnant women at the beginning of their second trimester living with their male partners at the time of the study.

Randomization will be conducted at the cluster level. Clusters will be Kebeles'. There will be 16 clusters or Kebeles. Data collectors (assessors) will be masked. The trial sample size will be 320 [160 in each arm]. A Generalized Estimating Equations model will be used. Data analysis will be conducted by SPSS or STATA software (as appropriate) using an Intention-To-Treat Approach. The duration of the intervention will be six months.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teklemariam E Yarinbab, MPH; Phone Number: +251930504891; Email: teklemariam36@gmail.com
• Study Contact Backup: Name: Tefera Belachew, PhD; Phone Number: +251917804072; Email: teferabelachew2@gmail.com

Study Locations

• Ethiopia
  • Oromia
    • Jimma, Oromia, Ethiopia, 378
      • Recruiting
      • Jimma University
      • Contact: Teklemariam Yarinbab, MPH; Phone Number: +251930504891; Email: teklemariam36@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pregnant women at the beginning of second trimesters (14-16 weeks of gestation)
• Pregnant women currently live with their male partners
• Pregnant women permanent residents of the study area
• Pregnant women live in a place ≥2 hours of walking distance from the nearest health facility and/or have no access to public transportation
• Pregnant women whose husbands/male partners will be willing to participate in the study

Exclusion Criteria:

• Pregnant women ≤ 13 weeks of gestation
• Pregnant women not living with their male partners at the time of the study
• Pregnant women who are not permanent residents of the study area
• Pregnant women live in a place < 2 hours of walking distance from the nearest health facility or have access to transportation
• Pregnant women whose husbands are not willing to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; The behavioral intervention will be conducted on the experimental group for consecutive six months. The components of the intervention will be group health education, provision of IEC materials/Leaflets, and home visits.	Behavioral: Behavioral intervention; A cluster-randomized controlled trial will be conducted.
NO_INTERVENTION: Control; The routine care will be continued in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization of MWH	Utilization of MWH is the use of MWHs by pregnant women in their final weeks of pregnancy to bridge the geographic gap in obstetric care. It is the proportion of pregnant women who use MWHs in the final weeks of pregnancy among the eligible women who are study participants.	up to six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Maternal Knowledge and Attitude	Knowledge will be measured using 'Yes' or 'No' questions and attitude will be measured using the Likert scale. There will be 7 questions for the knowledge assessment and 5 questions with 5 points Likert scales for the attitude assessment. Individual scores on each item will be added to yield the sum score. Participants who score above the median in the assessment will be regarded to be knowledgeable or have a good attitude about MWHs, while those who score below the median will be judged to have poor knowledge or an unfavorable attitude.	up to six months

Collaborators and Investigators

• Sponsor: Jimma University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (ACTUAL): August 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: maternity waiting home, male partner, Ethiopia
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Parental Death; Maternal Death
• Other Study ID Numbers: RP0901/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No