- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06564922
Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding
Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding During First Month at Bule Hora University Teaching Hospital and Yabelo General Hospital, Oromia, Ethiopia
Breastfeeding is crucial for the health of both mothers and infants, promoting healthier populations and reducing long-term healthcare costs. To maximize these benefits, education, support, and effective policies are essential. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation and exclusive breastfeeding rates in the pastoralist areas of Oromia, Ethiopia.
Hypothesis: Individualized immediate postnatal counselling improve exclusive breastfeeding practice.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Oromia
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Bulē, Oromia, Ethiopia
- Bule Hora and Yabelo Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Gave birth by spontaneous vaginal delivery
- Residents of either Yabelo or Bule Hora town hospital
- willing to participate in the study Exclusion Criteria
- Seriously ill and planned to move during the study period
- Stillbirth
- Neonatal death
- Gave birth cesarean delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Postnatal Counselling on Exclusive Breast Feeding
Counseling on exclusive breastfeeding (EBF) emphasizes starting within the first hour after birth and maintaining it for six months.
It covers feeding frequency, proper positioning, and attachment techniques to enhance breastfeeding effectiveness.
Benefits include reduced neonatal infections and lower maternal disease risks.
The counseling warns against mixed feeding, which can lead to increased infection susceptibility and malnutrition.
It also highlights postpartum danger signs in newborns, such as fever and irritability, encouraging early medical intervention.
This comprehensive approach aims to empower mothers with knowledge, promoting healthier breastfeeding practices and improving outcomes for both mother and child.
|
Counselling was given for treatment group.
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No Intervention: Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding
Usual counselling will be given.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Early initiation of breastfeeding
Time Frame: up to 1month
|
Mothers will be asked about their infant breastfeeding practices, specifically regarding the early initiation of breastfeeding.
The practice of early infant breastfeeding initiation will be determined using the operational definition of those who started breastfeeding within one hour after birth, while those who did not initiate breastfeeding within the first hour will be categorized accordingly.
|
up to 1month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Breastfeeding frequency
Time Frame: up to 1 month
|
Frequency of breast-feeding: This section describes the practice of mothers feeding their infants breast milk on demand.
In this study, instances where mothers fed their babies according to their needs and the program guidelines were coded as "0," while instances where babies required feeding were coded as "1."
Therefore, a code of "1" indicates that the mother frequently breastfed, whereas a code of "0" indicates that she did not frequently breastfeed.
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up to 1 month
|
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Mother knowledge and attitude
Time Frame: up to 1 month
|
Knowledge was assessed by evaluating their understanding of the benefits of breastfeeding for both themselves and their newborns. This evaluation involved eight specific questions. Mothers who answered at or above the mean score were classified as knowledgeable, while those who scored below the mean were considered not knowledgeable. Attitude: This study assesses attitudes through 10 questions on a five-point likert scale ranging from "strongly agree" to "strongly disagree." Responses are then simplified into a two-point scale (agree or disagree), with "1" assigned for agreement on positive questions and "0" for disagreement. The reverse applies for negative questions. A positive attitude is indicated by responses that meet or exceed the mean score for breastfeeding items, while scores below the mean indicate a negative attitude. |
up to 1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Belda N Beyene, MSc, Bule Hora University, Ethiopia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BuleHoraU
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.
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