An interventional study of Behavioral intervention in Maternal Death and Maternal Behavior, sponsored by Jimma University. Status unknown at 1 site in Ethiopia. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Jimma University · Not applicable, Interventional, and Health services research
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.
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 320 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →Jimma University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
The routine care will be continued in the control group.
A cluster-randomized controlled trial will be conducted.
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.
Time frame: up to six months
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.
Time frame: up to six months
Plan to share: No — There is no plan to make IPD available.
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for May 2023, 6 months after the start.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's planned 6 months is below that.
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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