- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06827600
Breastfeeding Intention and Breastfeeding Attitudes in the Postpartum Period
The Effect of Breastfeeding Training Given to Nulliparous Pregnant Women Before Cesarean Section on Breastfeeding Intention and Attitudes in the Postpartum Period: A Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Cesarean section rates are increasing every year worldwide and in Turkey. Due to the effects of anesthesia and pain in the cesarean area, breastfeeding and continuing breastfeeding are difficult. Breastfeeding is very important for maintaining the healthy growth of newborns, preventing future health problems such as obesity and cardiovascular diseases, and for maternal health. For these reasons, the World Health Organization (WHO) recommends that babies be fed only breast milk for the first six months and that breastfeeding should continue for two years.
Data from the Organization for Economic Co-operation and Development (OECD) indicate that numerous countries have cesarean section rates that surpass the recommended thresholds. Notably, Turkey has the highest cesarean section rate at 53.1%. Research has demonstrated that cesarean deliveries can pose challenges in initiating and sustaining breastfeeding.
Achieving WHO's 2030 goals on breast milk and breastfeeding, increasing breast milk intake, and increasing breastfeeding rates at the national level will directly contribute to maternal and child health and indirectly reduce family and health expenditures. However, when previous studies in the literature are examined, it is known that cesarean births, the effects of anesthesia, and pain in the cesarean area make breastfeeding and continuing breastfeeding a difficult factor.
This research project, which is planned as a randomized controlled experimental study, will be carried out to determine the effect of breastfeeding education and support given to nulliparous pregnant women before cesarean on breastfeeding intentions and breastfeeding attitudes in the postpartum period.
Research Questions:
- Is there a difference between the breastfeeding intentions of women in the experimental and control groups before the education intervention?
- Is there a difference between the breastfeeding intentions of women in the experimental and control groups after the education intervention?
- Is there a difference between the time when women who received breastfeeding education and support and women who did not receive it started breastfeeding?
- Is there a difference in the attitudes of women who received breastfeeding education and support and those who did not receive cesarean section regarding breastfeeding in the postpartum period?
- 5. Is there a difference in the delivery times between women who receive breastfeeding education and support and those who do not?
The project aims to ensure that mothers who gave birth by cesarean section and were given breastfeeding education and support will feed their babies exclusively with breast milk for at least 6 months to continue their breastfeeding intention and breastfeeding attitude and to increase the breastfeeding rates of mothers who gave birth by cesarean section.
Target measurements
- Before and after education (while pregnant before cesarean section)
- During discharge (postpartum period),
- In the first, third, and sixth months after discharge, the process will be conducted by phone call.
It aims to analyze and report the results of the newborn breastfeeding duration intention and breastfeeding attitude scale scores of the experimental and control groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bursa, Turkey, 16059
- Uludag University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older,
- Speaking and understanding Turkish,
- Having a planned Caesarean section,
- Being nulliparous
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
The control group was in the usual care.
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|
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Experimental: Experimental group
The experimental group in this study received structured breastfeeding education in addition to the standard care provided by healthcare professionals.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infant feeding Intentions before Intervention
Time Frame: before Intervention (37th and 42nd weeks of pregnancy)
|
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
Time Frame: after Intervention (37th and 42nd weeks of pregnancy)
|
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
Time Frame: Postpartum 3rd day
|
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
|
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Breastfeeding attitude before discharge
Time Frame: Postpartum 3rd day
|
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.
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Postpartum 3rd day
|
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Breastfeeding intentions: postpartum 1st month
Time Frame: 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
|
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Breastfeeding attitude: postpartum 1st month
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
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Breastfeeding Intentions: postpartum 6th month
Time Frame: 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
|
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Breastfeeding attitude: postpartum 6th month
Time Frame: Postpartum 6th month
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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.
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Postpartum 6th month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The starting breastfeeding in the first hour
Time Frame: Postpartum 3rd day
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Assessed using the Breastfeeding Follow-up Form in 3rd day postpartum.
Mothers reported whether they started breastfeeding within the first hour after birth
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Postpartum 3rd day
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Bottle feeding
Time Frame: Postpartum 3rd day
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Assessed using the Breastfeeding Follow-up Form in 3rd day postpartum. Mothers reported whether they started breastfeeding within the first hour after birth. Mothers reported whether they feed her baby with exclusively mother's milk. |
Postpartum 3rd day
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Exclusively feeding with mother's milk
Time Frame: postpartum 1sth month
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Breastfeeding was assessed using the Breastfeeding Follow-up Form. Mothers provided information regarding whether they practiced exclusive breastfeeding during the first month following the birth of their child. Mothers reported whether they feed her baby with exclusively mother's milk. |
postpartum 1sth month
|
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Exclusively feeding with mother's milk
Time Frame: Postpartum 3rd month
|
Breastfeeding was assessed using the Breastfeeding Follow-up Form.
Mothers provided information regarding whether they practiced exclusive breastfeeding during the 3rd month following the birth of their child.
|
Postpartum 3rd month
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Exclusively feeding with mother's milk
Time Frame: Postpartum 6th month
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Breastfeeding was assessed using the Breastfeeding Follow-up Form.
Mothers provided information regarding whether they practiced exclusive breastfeeding during the 6th month following the birth of their child.
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Postpartum 6th month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gonca Buran, Uludag University
Publications and helpful links
General Publications
- 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.
- Güneri, S. E., Muslu, G. K., & Güner, Ö. (2019). The Turkish Version of the Infant Feeding Intention Instrument (IFI-T). 41(3): 269-74
- 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.
- 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.
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
- 915
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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