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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Ethiopia
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Counselling
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bule Hora University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BuleHoraU

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.

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