Clinical trial NCT05517577: An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Integrated Community-based Intervention Package
Breastfeeding, Exclusive
Morbidity;Newborn
Complementary Feeding
Knowledge, Attitudes, Practice
Food Security
Birth Preparedness and Complication Readiness Plan
Neonatal Care
Health Care Seeking Behavior
Delivery Care
Postnatal Care
Keywords: community-based intervention,
maternal,
neonatal,
infant,
health outcome,
randomized controlled trial
Lead sponsor: Jimma University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 624
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Neonatal care practices
timeFrame: At month one after delivery
measure: Feeding practice
timeFrame: At month one after delivery
Secondary outcomes:
measure: Neonatal morbidity
timeFrame: At month one after delivery
measure: Maternal morbidity
timeFrame: At month one after delivery
measure: Birth preparedness and complication readiness plan
timeFrame: At month one after delivery
measure: Maternal feeding practice
timeFrame: : At month one after delivery
measure: Skilled delivery
timeFrame: At month one after delivery
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
state: Oromia
Study officials:
affiliation: Jimma University
name: Bekelu Teka, MPH
role: PRINCIPAL_INVESTIGATOR
References: