NCT06564922

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 12, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Breast feedingEarly initiation of breast feedingExclusive breast feedingImmediate counsellingRandomized controlled trialOromiaEthiopia

Outcome Measures

Primary Outcomes (1)

  • Early initiation of breastfeeding

    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 Outcomes (2)

  • Breastfeeding frequency

    up to 1 month

  • Mother knowledge and attitude

    up to 1 month

Study Arms (2)

Postnatal Counselling on Exclusive Breast Feeding

EXPERIMENTAL

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

Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding

NO INTERVENTION

Usual counselling will be given.

Interventions

Counselling was given for treatment group.

Postnatal Counselling on Exclusive Breast Feeding

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Seriously ill and planned to move during the study period
  • Stillbirth
  • Neonatal death
  • Gave birth cesarean delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bule Hora and Yabelo Hospital

Bulē, Oromiya, Ethiopia

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Counseling

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Belda N Beyene, MSc

    Bule Hora University, Ethiopia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The intervention will be single-blinded. The outcome assessors will be masked.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 21, 2024

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 1, 2023

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations