An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes

Knowledge, Attitudes, Practice Clinical Trial

— ICBIP-MNH)  

Official title:

Effectiveness of an Integrated Community-based Intervention Package in Improving Maternal, and Neonatal Health Outcome in Jimma Zone, Southwest Ethiopia: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517577
• Other study ID #: JUIH/IRB/110/22
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Breastfeeding, Exclusive
• Complementary Feeding
• Food Security
• Health Care Seeking Behavior
• Knowledge, Attitudes, Practice
• Morbidity;Newborn
• Neonatal Care

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