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

Primary Purpose

Maternal Death, Maternal Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Behavioral intervention
Sponsored by
Jimma University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Death focused on measuring maternity waiting home, male partner, Ethiopia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jimma UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

The routine care will be continued in the control group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2021
Last Updated
February 3, 2023
Sponsor
Jimma University
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1. Study Identification

Unique Protocol Identification Number
NCT05015023
Brief Title
Effectiveness of Health Education Provided to Couples on Utilization of Maternity Waiting Homes in Rural Ethiopia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jimma University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Death, Maternal Behavior
Keywords
maternity waiting home, male partner, Ethiopia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will have two arms, i.e., intervention and control groups.
Masking
Outcomes Assessor
Masking Description
The outcome assessors will be masked.
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The routine care will be continued in the control group.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention
Intervention Description
A cluster-randomized controlled trial will be conducted.
Primary Outcome Measure Information:
Title
Utilization of MWH
Description
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.
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
Level of Maternal Knowledge and Attitude
Description
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.
Time Frame
up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teklemariam E Yarinbab, MPH
Phone
+251930504891
Email
teklemariam36@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tefera Belachew, PhD
Phone
+251917804072
Email
teferabelachew2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teklemariam E Yarinbab, MPH
Organizational Affiliation
Mizan Tepi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hailay A Gesesew, PhD
Organizational Affiliation
Torrens University Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tefera Belachew, PhD
Organizational Affiliation
Jimma University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jimma University
City
Jimma
State/Province
Oromia
ZIP/Postal Code
378
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teklemariam Yarinbab, MPH
Phone
+251930504891
Email
teklemariam36@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available.

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

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