Clinical trial NCT06827600: Breastfeeding Intention and Breastfeeding Attitudes in the Postpartum Period
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section
Nulliparous
Breastfeeding, Exclusive
Breastfeeding Attitude
Keywords: Caesarean section
Nulliparous
Breastfeeding, Exclusive
Breastfeeding attitude
Breastfeeding intention
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-02-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Primary purpose: SUPPORTIVE_CARE

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.

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:

1. Is there a difference between the breastfeeding intentions of women in the experimental and control groups before the education intervention?
2. Is there a difference between the breastfeeding intentions of women in the experimental and control groups after the education intervention?
3. Is there a difference between the time when women who received breastfeeding education and support and women who did not receive it started breastfeeding?
4. 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant feeding Intentions before Intervention
timeFrame: before Intervention (37th and 42nd weeks of pregnancy)
measure: Breastfeeding intentions after Intervention
timeFrame: after Intervention (37th and 42nd weeks of pregnancy)
measure: Breastfeeding intentions before discharge
timeFrame: Postpartum 3rd day
measure: Breastfeeding attitude before discharge
timeFrame: Postpartum 3rd day
measure: Breastfeeding intentions: postpartum 1st month
timeFrame: Postpartum 1st month
measure: Breastfeeding attitude: postpartum 1st month
timeFrame: Postpartum 1st month
measure: Breastfeeding Intentions: postpartum 3rd month
timeFrame: Postpartum 3rd month
measure: Breastfeeding attitude: postpartum 3rd month
timeFrame: Postpartum 3rd month
measure: Breastfeeding Intentions: postpartum 6th month
timeFrame: Postpartum 6th month
measure: Breastfeeding attitude: postpartum 6th month
timeFrame: Postpartum 6th month
Secondary outcomes:
measure: The starting breastfeeding in the first hour
timeFrame: Postpartum 3rd day
measure: Bottle feeding
timeFrame: Postpartum 3rd day
measure: Exclusively feeding with mother's milk
timeFrame: postpartum 1sth month
measure: Exclusively feeding with mother's milk
timeFrame: Postpartum 3rd month
measure: Exclusively feeding with mother's milk
timeFrame: Postpartum 6th month
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University
Study officials:
affiliation: Uludag University
name: Gonca Buran
role: PRINCIPAL_INVESTIGATOR
References:
citation: Güneri, S. E., Muslu, G. K., & Güner, Ö. (2019). The Turkish Version of the Infant Feeding Intention Instrument (IFI-T). 41(3): 269-74
citation: 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.
citation: 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.
citation: 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.