- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05517577
An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes (ICBIP-MNH))
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 Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bekelu Teka, MPH
- Phone Number: +251 945 031 001
- Email: bekelut23@gmail.com
Study Contact Backup
- Name: Misra Abdulahi, MPH
- Phone Number: +251912010293
- Email: misra_ab@yahoo.com
Study Locations
-
-
Oromia
-
Jimma, Oromia, Ethiopia, 378
- Recruiting
- Jimma University
-
Contact:
- Jimma University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
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.
Other Names:
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal care practices
Time Frame: At month one after delivery
|
Prevalence of neonatal care practices
|
At month one after delivery
|
Feeding practice
Time Frame: At month one after delivery
|
prevalence of early initiation and exclusive breastfeeding
|
At month one after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal morbidity
Time Frame: At month one after delivery
|
Prevalence of neonatal morbidity
|
At month one after delivery
|
Maternal morbidity
Time Frame: At month one after delivery
|
Prevalence of maternal morbidity
|
At month one after delivery
|
Birth preparedness and complication readiness plan
Time Frame: At month one after delivery
|
Proportion of women who had Birth preparedness and complication readiness plan
|
At month one after delivery
|
Maternal feeding practice
Time Frame: : At month one after delivery
|
Prevalence of minimum dietary diversity
|
: At month one after delivery
|
Skilled delivery
Time Frame: At month one after delivery
|
Prevalence of women who delivered at health institution
|
At month one after delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bekelu Teka, MPH, Jimma University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JUIH/IRB/110/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knowledge, Attitudes, Practice
-
St. Jude Children's Research HospitalRecruitingKnowledge, Attitudes, PracticeUnited States
-
Pamela HughesRecruitingKnowledge, Attitudes, PracticeUnited States
-
Hacettepe UniversityCompletedKnowledge, Attitudes, PracticeTurkey
-
Ahmad Nassar IbrahimAssiut UniversityUnknownKnowledge, Attitudes, Practice
-
Medical University of LodzCompletedKnowledge, Attitudes, PracticePoland
-
Maharishi Markendeswar University (Deemed to be...CompletedKnowledge, Attitudes, Practice
-
University of UtahNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingKnowledge, Attitudes, Practice
-
Boston CollegeNational Institute of Mental Health (NIMH)RecruitingKnowledge, Attitudes, PracticeUnited States
-
University of GuelphRecruitingKnowledge, Attitudes, PracticeCanada
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)Recruiting
Clinical Trials on Behaviour Change Communication and Male involvement intervention
-
Queen's UniversityMennonite Economic Development AssociatesCompleted
-
Aga Khan UniversityBenazir Income Support Programme (BISP); Department of Health, Government of... and other collaboratorsCompleted
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedCystic FibrosisUnited Kingdom
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedCystic FibrosisUnited Kingdom
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
Wageningen UniversityRijnstate Hospital; Flevoziekenhuis; Deventer Ziekenhuis; World Cancer Research... and other collaboratorsActive, not recruitingColorectal Cancer | Rectal Cancer | Colon Cancer | Cancer-related FatigueNetherlands
-
Allurion TechnologiesCompleted
-
WorldFishMercy CorpsRecruiting
-
Clinical Research Centre, MalaysiaMinistry of Health, Malaysia; National University of Malaysia; Institute for...Not yet recruitingBreast Neoplasm FemaleMalaysia
-
Glasgow Caledonian UniversityKing's College London; St George's, University of London; University of Glasgow; NHS LanarkshireRecruitingIntermittent Claudication | Peripheral Artery DiseaseUnited Kingdom