Clinical trial NCT05015023: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Death
Maternal Behavior
Keywords: maternity waiting home, male partner, Ethiopia
Lead sponsor: Jimma University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 320
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have two arms, i.e., intervention and control groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Utilization of MWH
timeFrame: up to six months
Secondary outcomes:
measure: Level of Maternal Knowledge and Attitude
timeFrame: up to six months
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
state: Oromia
Study officials:
affiliation: Mizan Tepi University
name: Teklemariam E Yarinbab, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Torrens University Australia
name: Hailay A Gesesew, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jimma University
name: Tefera Belachew, PhD
role: PRINCIPAL_INVESTIGATOR
References: