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

NCT ID: NCT05015023

Last Updated: 2023-02-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Maternal Death Maternal Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will have two arms, i.e., intervention and control groups.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessors will be masked.

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral intervention

Intervention Type BEHAVIORAL

A cluster-randomized controlled trial will be conducted.

Control

The routine care will be continued in the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral intervention

A cluster-randomized controlled trial will be conducted.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jimma University

OTHER

Sponsor Role lead

Responsible Party

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Teklemariam Yarinbab, MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teklemariam E Yarinbab, MPH

Role: PRINCIPAL_INVESTIGATOR

Mizan Tepi University

Hailay A Gesesew, PhD

Role: PRINCIPAL_INVESTIGATOR

Torrens University Australia

Tefera Belachew, PhD

Role: PRINCIPAL_INVESTIGATOR

Jimma University

Locations

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Jimma University

Jimma, Oromiya, Ethiopia

Site Status RECRUITING

Countries

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Ethiopia

Central Contacts

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Teklemariam E Yarinbab, MPH

Role: CONTACT

+251930504891

Tefera Belachew, PhD

Role: CONTACT

+251917804072

Facility Contacts

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Teklemariam Yarinbab, MPH

Role: primary

+251930504891

References

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Yarinbab TE, Gesesew HA, Belachew T. Effect of health education provided to couples on maternal knowledge, attitude and use of maternity waiting homes in rural Ethiopia: A cluster-randomized trial. Midwifery. 2024 Nov;138:104153. doi: 10.1016/j.midw.2024.104153. Epub 2024 Aug 22.

Reference Type DERIVED
PMID: 39197275 (View on PubMed)

Yarinbab TE, Gesesew HA, Harrison MS, Belachew T. Effect of couple-based health education on male-partners knowledge and attitude towards maternity waiting homes in rural Ethiopia: a cluster-randomized trial. Sci Rep. 2023 Oct 27;13(1):18446. doi: 10.1038/s41598-023-45681-4.

Reference Type DERIVED
PMID: 37891206 (View on PubMed)

Other Identifiers

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RP0901/11

Identifier Type: -

Identifier Source: org_study_id

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