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

Maternal Behavior Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015023
• Other study ID #: RP0901/11
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Jimma University
• Contact: Teklemariam E Yarinbab, MPH
• Phone: +251930504891
• Email: teklemariam36[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Behavior
• Maternal Death

Intervention

Behavioral:
• Behavioral intervention
A cluster-randomized controlled trial will be conducted.

Locations

Country	Name	City	State
Ethiopia	Jimma University	Jimma	Oromia

Sponsors (1)

Lead Sponsor	Collaborator
Jimma University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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