Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding

NCT ID: NCT06564922

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-05-01

Brief Summary

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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.

Detailed Description

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Breastfeeding plays a crucial role in promoting the health and well-being of both mothers and their infants, contributing to healthier populations, and reducing long-term healthcare costs. Encouraging breastfeeding through education, support, and policies is essential for maximizing these benefits. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation of breastfeeding rates and exclusive breastfeeding in Bule Hora and Yabelo Hospitals. A cluster randomized single-blinded trial was conducted on 224 pregnant women (112 for the intervention group and 112 for the control group) from January 1, 2023, to April 30, 2023. The effect of immediate postpartum counselling and its associated variables on early initiation and exclusive breastfeeding practices were evaluated using multiple logistic regressions. A p-value of less than 0.05, a 95% confidence interval, and an adjusted odd ratio were used to determine statistical significance.

Conditions

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Breast Feeding Counselling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study will have two arms, i.e., intervention and control groups. The intervention group will receive immediate postnatal breastfeeding counselling and control group will receive routine care.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The intervention will be single-blinded. The outcome assessors will be masked.

Study Groups

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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.

Group Type EXPERIMENTAL

Counselling

Intervention Type OTHER

Counselling was given for treatment group.

Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding

Usual counselling will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counselling

Counselling was given for treatment group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gave birth by spontaneous vaginal delivery
* Residents of either Yabelo or Bule Hora town hospital

Exclusion Criteria

* Seriously ill and planned to move during the study period
* Stillbirth
* Neonatal death
* Gave birth cesarean delivery
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bule Hora University

OTHER

Sponsor Role lead

Responsible Party

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Belda Negesa Beyene

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Belda N Beyene, MSc

Role: PRINCIPAL_INVESTIGATOR

Bule Hora University, Ethiopia

Locations

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Bule Hora and Yabelo Hospital

Bulē, Oromiya, Ethiopia

Site Status

Countries

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Ethiopia

Other Identifiers

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BuleHoraU

Identifier Type: -

Identifier Source: org_study_id

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