NCT06827600

Brief Summary

Purpose: It will be carried out to determine the effect of breastfeeding education given to nulliparous pregnant women before cesarean section on breastfeeding intention and breastfeeding attitudes in the postpartum period. Material method: The research, planned as a randomized controlled experimental study, will be carried out with a total of 70 mothers who are hospitalized in the Maternity Clinic of Bursa Uludağ University Research and Practice Hospital and who meet the study assignment criteria and who are determined by simple randomization method. Breastfeeding education and support will be provided to 35 women in the experimental group, and 35 women in the control group will be left to the hospital's usual care. Data will be collected between April 2024 and January 2025 using the "Introductory Form," "Newborn Feeding Intention Scale," and "Breastfeeding Attitude Evaluation Scale." The educational intervention will be carried out one-on-one in the woman's own room during the prenatal period for the women allocated to the experimental group. In addition to the explanation, question and answer, and visual material use, the demonstration technique with a newborn model will be used in the education. A booklet containing written illustrated breastfeeding education prepared in line with the literature will be given to mothers with cesarean delivery. The data will be filled in the "Introductory Information Form," "Newborn Feeding Intention Scale," and "Breastfeeding Attitude Assessment Scale." The data of the study will be analyzed in the Statistical Package for the Social Sciences (SPSS) for Windows 20.0 package program. Descriptive statistics (arithmetic mean, minimum-maximum, standard deviation, number, and percentage), Student t-test, one-way analysis of variance (ANOVA), Mann-Whitney U test, and Kruskal-Wallis test will be used in the analysis of the data. Expected Result: Determining the effect of breastfeeding education given to nulliparous pregnant women before cesarean section on breastfeeding intention and breastfeeding attitudes in the postpartum period will guide health professionals. It will be a resource for studies that can be conducted on different sample groups and in different regions on the subject and will contribute to national and international literature and scientific knowledge with the publication to be made.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

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

April 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 27, 2025

Last Update Submit

February 10, 2025

Conditions

Keywords

Caesarean sectionNulliparousBreastfeeding, ExclusiveBreastfeeding attitudeBreastfeeding intention

Outcome Measures

Primary Outcomes (10)

  • Infant feeding Intentions before Intervention

    Before the breastfeeding education intervention, the "Infant Feeding Intentions Scale" was applied to the pregnant women in the experimental and control groups. The intentions of the pregnant women in both groups to breastfeed their babies were evaluated.According to the score of the Infant Feeding Intentions Scale, breastfeeding intention is classified as follows: (0-3.5) very low, (4.0-7.5) low, (8.0-11.5) moderate, (12.0-15.5) strong and (16.0) very strong.

    before Intervention (37th and 42nd weeks of pregnancy)

  • Breastfeeding intentions after Intervention

    After the breastfeeding education intervention in the experimental group, the "Infant Feeding Intentions Scale" was applied to the pregnant women in the experimental and control groups. The intentions of both groups to breastfeed their babies were determined.groups. The intentions of the pregnant women in both groups to breastfeed their babies were evaluated.According to the score of the Infant Feeding Intentions Scale, breastfeeding intention is classified as follows: (0-3.5) very low, (4.0-7.5) low, (8.0-11.5) moderate, (12.0-15.5) strong and (16.0) very strong.

    after Intervention (37th and 42nd weeks of pregnancy)

  • Breastfeeding intentions before discharge

    Before discharge, mothers in both the experimental and control groups were administered the "Infant Feeding Intentions Scale". The intentions of the mothers in both groups to breastfeed their babies were evaluated. According to the score of the Infant Feeding Intentions Scale, breastfeeding intention is classified as follows: (0-3.5) very low, (4.0-7.5) low, (8.0-11.5) moderate, (12.0-15.5) strong and (16.0) very strong. As the score of the breastfeeding attitude scale increases, it is evaluated that the breastfeeding attitude is positive. The scale has no subgroups.

    Postpartum 3rd day

  • Breastfeeding attitude before discharge

    Before discharge, mothers in both the experimental and control groups were administered the "Breastfeeding Attitude Scale." This instrument yields scores ranging from 0 to 184, with one item being reverse-scored. An increase in the score reflects a more positive attitude toward breastfeeding.

    Postpartum 3rd day

  • Breastfeeding intentions: postpartum 1st month

    The mothers in the experimental and control groups were assessed using the "Infant Feeding Intentions Scale" on the first month postpartum. According to the score of the Infant Feeding Intentions Scale, breastfeeding intention is classified as follows: (0-3.5) very low, (4.0-7.5) low, (8.0-11.5) moderate, (12.0-15.5) strong and (16.0) very strong. As the breastfeeding attitude scale scores increase, it is evaluated that the breastfeeding attitude is positive. The scale has no subgroups.

    Postpartum 1st month

  • Breastfeeding attitude: postpartum 1st month

    The mothers in the experimental and control groups were assessed using the "Breastfeeding Attitude Assessment Scale" during the first month postpartum. This instrument yields scores ranging from 0 to 184, with one reverse-scored item. An increase in the score reflects a more positive attitude toward breastfeeding.

    Postpartum 1st month

  • Breastfeeding Intentions: postpartum 3rd month

    The mothers in the experimental and control groups were assessed using the "Infant Feeding Intentions Scale" on the 3rd month postpartum. According to the score of the Infant Feeding Intentions Scale, breastfeeding intention is classified as follows: (0-3.5) very low, (4.0-7.5) low, (8.0-11.5) moderate, (12.0-15.5) strong and (16.0) very strong. As the breastfeeding attitude scale scores increase, it is evaluated that the breastfeeding attitude is positive. The scale has no subgroups.

    Postpartum 3rd month

  • Breastfeeding attitude: postpartum 3rd month

    The mothers in the experimental and control groups were assessed using the "Breastfeeding Attitude Assessment Scale" during the 3rd month postpartum. This instrument yields scores ranging from 0 to 184, with one reverse-scored item. An increase in the score reflects a more positive attitude toward breastfeeding.

    Postpartum 3rd month

  • Breastfeeding Intentions: postpartum 6th month

    The mothers in the experimental and control groups were assessed using the "Infant Feeding Intentions Scale" on the 6th month postpartum. According to the score of the Infant Feeding Intentions Scale, breastfeeding intention is classified as follows: (0-3.5) very low, (4.0-7.5) low, (8.0-11.5) moderate, (12.0-15.5) strong and (16.0) very strong. As the breastfeeding attitude scale scores increase, it is evaluated that the breastfeeding attitude is positive. The scale has no subgroups.

    Postpartum 6th month

  • Breastfeeding attitude: postpartum 6th month

    In the 6th month postpartum, mothers in both the experimental and control groups underwent evaluation using the "Breastfeeding Attitude Assessment Scale." This scale generates scores ranging from 0 to 184, with one item scored in reverse. An increase in the total score signifies a more positive attitude toward breastfeeding.

    Postpartum 6th month

Secondary Outcomes (5)

  • The starting breastfeeding in the first hour

    Postpartum 3rd day

  • Bottle feeding

    Postpartum 3rd day

  • Exclusively feeding with mother's milk

    postpartum 1sth month

  • Exclusively feeding with mother's milk

    Postpartum 3rd month

  • Exclusively feeding with mother's milk

    Postpartum 6th month

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group in this study received structured breastfeeding education in addition to the standard care provided by healthcare professionals.

Behavioral: Structured breastfeeding education and follow-up

Control group

NO INTERVENTION

The control group was in the usual care.

Interventions

Breastfeeding education was provided face-to-face to mothers assigned to the experimental group. The authors developed a breastfeeding education program and prepared a booklet. This booklets were distributed to experimental group.Follow-up were carried out on the 3rd day and at the 1st, 3rd, and 6th months postpartum. each follow-up session, the educational program's core components were reinforced through a standardized summary, ensuring continuity and clarity in the information provided. Training Content * Significance of Breastfeeding * Advantages of Breastfeeding * Overview of Colostrum * Duration for Breastfeeding * Breastfeeding Positions * Strategies for Enhancing Breast Milk Production * Increasing Breast Milk Supply * Techniques for Placing the Baby on the Breast * Implications of Improper Baby Positioning * Indicators of Sufficient Breast Milk for the Infant * Expressing Breast Milk * Recommendations for Storing Expressed Milk

Experimental group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being 18 years of age or older,
  • Speaking and understanding Turkish,
  • Having a planned Caesarean section,
  • Being nulliparous

You may not qualify if:

  • Having a history of psychological or mental health problems
  • Having any condition in the mother or infant that was a barrier to breastfeeding (using medication that passes into breast milk, breast structure not being suitable for milk production, mastectomy operation, etc.)
  • The baby's admission into the neonatal unit
  • The baby's separation from the mother for any reason
  • Having a disease (anomaly, cleft palate and lip, etc.) that prevents the baby from breastfeeding,
  • Having given childbirth outside of the 37-42nd week,
  • Having a baby with a birth weight below 2500 grams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University

Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (4)

  • Güneri, S. E., Muslu, G. K., & Güner, Ö. (2019). The Turkish Version of the Infant Feeding Intention Instrument (IFI-T). 41(3): 269-74

    BACKGROUND
  • Buran G, Ozyazicioglu N, Aydin AI, Atak M. Evaluation of breastfeeding success and self-efficacy in mothers giving birth via vaginal delivery or cesarean section: a cross-sectional study. Women Health. 2022 Oct-Dec;62(9-10):788-798. doi: 10.1080/03630242.2022.2146832. Epub 2022 Nov 20.

    PMID: 36404416BACKGROUND
  • Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.

  • Li L, Wan W, Zhu C. Breastfeeding after a cesarean section: A literature review. Midwifery. 2021 Dec;103:103117. doi: 10.1016/j.midw.2021.103117. Epub 2021 Aug 14.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Gonca Buran

    Uludag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The Care Provider and Outcome Assessor will be kept unaware of the experimental and control groups participating in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN, Assit. Prof.

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 14, 2025

Study Start

April 3, 2024

Primary Completion

July 30, 2024

Study Completion

January 27, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations