- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757324
Breast Milk and Breastfeeding Education Given in the Antenatal Period (BSES-SF)
The Influence of Breast Milk and Breastfeeding Education Given in the Antenatal Period on Breastfeeding Success and Breastfeeding Self-efficacy: Randomize Control Trials
Study Overview
Detailed Description
Practices for increasing breastfeeding self-efficacy are of vital importance and they increase the level of breastfeeding self-efficacy. Breast milk and breastfeeding educations have given in the ante-natal period are another way of increasing the success of breastfeeding.
In this experimental investigation, 80 pregnant women who attended a baby-friendly hospital were randomly assigned to the education (n = 40) or control (n = 40) groups. The pregnant women in the intervention group received 4 hours of human milk and breastfeeding educational sessions along with routine care and furthermore, a brochure prepared by the researcher was given. All women whose estimated delivery date had approximated were questioned about whether they had given birth or not, and the sociodemographic data form, the LATCH Breastfeeding Assessment Tool and the Breastfeeding Self-efficacy Scale-short form were applied to the subjects in the education and the control group by visiting them at home when the post-partum first week had been completed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
inclusion criteria Being above 18 years of age, Having completed the 26th gestational week (At training phase), Having no problem with vision and hearing, Having no disease that can prevent breastfeeding, Having a pregnancy with no risk, Having no systemic disease, Planning to breastfeed after birth
excusion criteria the mother stops researching. treating the baby in neonatal intensive care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: education arm
Breastfeeding training was given to the training arm
|
Other Names:
|
|
NO_INTERVENTION: control arm
Breastfeeding training not given to control arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in self-efficacy on the 70 points Breastfeeding Self-efficacy Scale-short form at week 1
Time Frame: baseline and week 1
|
baseline and week 1
|
|
|
Change from baseline in LATCH score on the 70 points LATCH Breastfeeding Assessment Toolform at week 1
Time Frame: baseline in week 1
|
breastfeeding success
|
baseline in week 1
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
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
- Breastfeeding Education
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
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