Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding

August 19, 2024 updated by: Belda Negesa Beyene, Bule Hora University

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

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oromia
      • Bulē, Oromia, Ethiopia
        • Bule Hora and Yabelo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
No Intervention: Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding
Usual counselling will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Belda N Beyene, MSc, Bule Hora University, Ethiopia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Breast Feeding

Clinical Trials on Counselling

Subscribe