An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes (ICBIP-MNH))

Jimma University

Status: Enrolling

Conditions: Integrated Community-based Intervention Package; Health Care Seeking Behavior; Complementary Feeding; Delivery Care; Morbidity;Newborn; Birth Preparedness and Complication Readiness Plan; Postnatal Care; Neonatal Care; Knowledge, Attitudes, Practice; Food Security; Breastfeeding, Exclusive

Treatments: Behavioral: Behaviour Change Communication and Male involvement intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05517577

JUIH/IRB/110/22

Details and patient eligibility

About

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

Full 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

Enrollment: 624 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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624 participants in 2 patient groups

Intervention group

Experimental group

Description:

An integrated Community-based package of interventions An integrated intervention consisting of behaviourchange communication, and male involvement will be delivered to pregnant women in their third trimester. They will receive 2 prenatal and five home visits. each visit will last 40-60 minutes. After delivery mother-newborn pairs will be followed up until six weeks.

Treatment:

Behavioral: Behaviour Change Communication and Male involvement intervention

Control group

No Intervention group

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. Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation.