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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05517577
Other study ID # JUIH/IRB/110/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 20, 2022
Est. completion date September 20, 2023

Study information

Verified date March 2023
Source Jimma University
Contact Bekelu Teka, MPH
Phone +251 945 031 001
Email bekelut23@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.


Description:

Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in low and middle-income countries. Community-based Interventions and strategies for improving maternal, newborn, and child health care have been recommended through a continuum of care approach. However, few efforts have been made to identify synergies and integrate different intervention packages across the country. Objective: This study aims to assess the effectiveness of an integrated community-based intervention package in improving maternal, neonatal and infant health outcomes in Jimma Zone, Southwest Ethiopia: a cluster randomized controlled trial. Methods: This is a parallel-arm, single-blind, cluster randomized controlled trial conducted in the Dedo and Seka Chekorsa districts of the Jimma zone. After excluding 10 kebeles from each district to be considered as a buffer zone, we will assign 26 kebeles to the intervention arm and 26 to the control arm. A total of 624 pregnant women in their third trimester who reside in the kebeles assigned to the intervention clusters will be identified and enrolled (312 in intervention and 312 in control groups). The intervention includes Behavioral Change Communication, and male involvement. Various multidisciplinary professionals and experts regularly monitor the overall process of the research and intervention activities. The effect of the intervention in comparison with the routine care will be assessed by fitting mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes. In all analyses, adjustment will be made for clustering at the kebele level and covariate. All tests will be two-sided and the level of significance will be set at alpha < 0.05. Budget: A total of 579,888.4ETB will be required. Key words: community-based intervention, maternal, neonatal, infant, health outcome, randomized controlled trial


Recruitment information / eligibility

Status Recruiting
Enrollment 624
Est. completion date September 20, 2023
Est. primary completion date April 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria: - Pregnant women in the third trimester - Live in the selected cluster Exclusion Criteria: - Serious illness or clinical complications requiring hospitalization - Maternal death - Newborn death - Stillbirth - Twin gestation - Preterm birth (at <37 weeks)

Study Design


Intervention

Behavioral:
Behaviour Change Communication and Male involvement intervention
For the integration of the intervention, it is planned to deliver both service at the same time a by the same means to the women and the men. Pregnant women who fail to take one of the intevetion will not be considered as the participant who received integrated intervention. The intervention will be provided through Women Developmental army (WDA) leaders imparted through gatherings and home visits whereas the Broadcast will be used to strengthen and as a frequent remidinng of the conveyed messages.

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 Neonatal care practices Prevalence of neonatal care practices At month one after delivery
Primary Feeding practice prevalence of early initiation and exclusive breastfeeding At month one after delivery
Secondary Neonatal morbidity Prevalence of neonatal morbidity At month one after delivery
Secondary Maternal morbidity Prevalence of maternal morbidity At month one after delivery
Secondary Birth preparedness and complication readiness plan Proportion of women who had Birth preparedness and complication readiness plan At month one after delivery
Secondary Maternal feeding practice Prevalence of minimum dietary diversity : At month one after delivery
Secondary Skilled delivery Prevalence of women who delivered at health institution At month one after delivery
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