- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410754
Effect of Combined Skin-to-Skin Contact and Kangaroo Care on Breastfeeding and Bonding in Cesarean-Born Newborns (SSC-CS)
The Effect of Consecutive Skin-to-Skin Contact Applied by the Mother and Father on Breastfeeding Parameters and Bonding in Babies Born by Cesarean Section
Study Overview
Status
Intervention / Treatment
Detailed Description
The global increase in cesarean section rates has become a significant public health concern. In Türkiye, the cesarean section rate reached 57.4% in 2023, one of the highest among OECD countries. Babies born by cesarean section are often deprived of early skin-to-skin contact in the immediate postnatal period due to maternal physical limitations, which may negatively affect breastfeeding outcomes and parent-infant bonding.
Skin-to-skin contact and kangaroo care are evidence-based practices known to support neonatal physiological stability, breastfeeding success, pain management, and parent-infant bonding. However, operational and clinical barriers following cesarean delivery often limit the early implementation of maternal skin-to-skin contact. While the effects of skin-to-skin contact have been extensively studied in the context of mother-infant dyads, evidence regarding father-infant skin-to-skin contact remains limited, particularly in term infants.
Delayed maternal contact following cesarean delivery may result in missed opportunities for early bonding and breastfeeding initiation. In this context, involving fathers in early skin-to-skin contact may provide an effective strategy to compensate for delayed maternal contact. Active paternal participation in newborn care has been shown to support infant development, enhance paternal role adaptation, and strengthen family bonding.
This randomized controlled study will be conducted in the delivery and postpartum units of a private mother- and baby-friendly hospital in Istanbul, Türkiye. The study population will consist of mothers and term newborns born by cesarean section who meet the inclusion criteria. Sample size will be determined using G*Power software.
Participants will be randomly assigned to one of two groups. In the intervention group, newborns will receive uninterrupted skin-to-skin contact with the father for 30 minutes immediately after birth. Painful procedures, including hepatitis B vaccination and vitamin K administration, will be performed during father-infant skin-to-skin contact. Following maternal recovery and confirmation of clinical suitability, consecutive skin-to-skin contact will be initiated between the mother and the newborn. The first breastfeeding attempt will occur during maternal skin-to-skin contact.
The control group will receive routine postnatal care according to the hospital's standard protocol.
Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool prior to discharge, on postpartum day 2, and at one month postpartum. Maternal and paternal bonding will be evaluated using the Maternal Postnatal Attachment Scale (MPAS) and the Paternal Postnatal Attachment Scale (PPAS) at the same time points. Breastfeeding parameters and parental bonding outcomes will be statistically compared between the two groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paria Study Coordinator / Midwife, MSc
- Phone Number: +905526018494
- Email: paria.mohammadiasl@ogr.iuc.edu.tr
Study Contact Backup
- Name: Sevil professor/Advisor, PhD
- Phone Number: 43162 +90 212 866 3700
- Email: sevil@iuc.edu.tr
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye)
- Zeytinburnu Avrasya Hospitol
-
Contact:
- Paria Study Coordinator / Midwife, MSc
- Phone Number: +905526018494
- Email: paria.mohammadiasl@ogr.iuc.edu.tr
-
Contact:
- Sevil professor/Advisor, PhD
- Phone Number: 43162 +90 212 866 3700
- Email: sevil@iuc.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Mothers who delivered by cesarean section
- Mothers and fathers willing to participate and provide written informed consent
- Newborns who are stable after birth
- No health conditions in mothers or fathers that would prevent participation in skin-to-skin contact
Exclusion criteria:
- Serious maternal or neonatal illness
- Newborns requiring NICU admission
- Mothers or fathers unwilling to participate
- Any maternal or paternal condition preventing the implementation of skin-to-skin contact
Additional note:
-Eligibility is based on biological sex (female for mothers, male for fathers, newborns of any sex), not on gender identity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Consecutive Skin-to-Skin Contact Group ( İntervention )
Newborns in this group receive consecutive skin-to-skin contact, first applied by the father for 30 minutes immediately after cesarean delivery, followed by skin-to-skin contact with the mother as soon as maternal clinical condition allows.
Routine newborn care is provided alongside the intervention.
|
Consecutive skin-to-skin contact is applied to newborns born by cesarean section, first by the father for 30 minutes immediately after birth, followed by skin-to-skin contact with the mother as soon as maternal clinical condition allows.
Routine newborn care is provided alongside the intervention.
|
|
No Intervention: Routine Care Group ( Control )
Newborns in this group receive routine postpartum and newborn care according to the hospital's standard clinical protocol following cesarean delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Postnatal Attachment Scale (MPAS)
Time Frame: 3 months
|
Maternal-infant attachment will be measured using the Maternal Postnatal Attachment Scale (MPAS).
This 19-item Likert-type self-report scale assesses the mother's emotions and thoughts toward her infant.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Paternal Postnatal Attachment Scale (PPAS)
Time Frame: 3 months
|
Paternal-infant attachment will be measured using the Paternal Postnatal Attachment Scale (PPAS).
This 19-item scale evaluates the father's emotional approach, involvement, and interaction with the infant.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bristol Breastfeeding Assessment Tool (BBAT)
Time Frame: 3 months
|
Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT).
The tool evaluates mother-infant interaction during breastfeeding, infant positioning, latch, and sucking effectiveness, providing a systematic score of breastfeeding performance.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: sevil İnal, PhD, Cerrahpaşa University, Faculty of Health Sciences, Midwifery Department
- Principal Investigator: Paria Mohammadiasl, MSc, Zeytinburu Avrasya Hospital / Cerrahpaşa University, Midwifery Department
Publications and helpful links
General Publications
- Martinez-Hortelano JA, Saz-Lara A, Gonzalez JLG, Cristobal-Aguado S, Iglesias-Rus L, Martinez-Vizcaino V, Garrido-Miguel M. Skin-to-skin contact and breastfeeding after caesarean section: A systematic review and meta-analysis of intervention studies. Int J Nurs Stud. 2025 Jun;166:105038. doi: 10.1016/j.ijnurstu.2025.105038. Epub 2025 Mar 5.
- Brochez L, Naeyaert JM. Understanding the trends in melanoma incidence and mortality: where do we stand? Eur J Dermatol. 2000 Jan-Feb;10(1):71-5; quiz 76.
- Nopp A, Stridh H, Gronneberg R, Lundahl J. Lower apoptosis rate and higher CD69 expression in neutrophils from atopic individuals. Inflamm Res. 2002 Nov;51(11):532-40. doi: 10.1007/pl00012424.
- Bagwe AN, Kay PH, Spagnolo DV. Evidence that DNA methylation imbalance is not involved in the development of malignant mesothelioma. Anticancer Res. 1997 Sep-Oct;17(5A):3341-3.
- Zarei Salehabadei M, Amini L, Haghani S, Sadeghi Avval Shahr H. Postpartum depression and paternal-infant attachment in Iranian fathers. J Reprod Infant Psychol. 2025 Mar 27:1-14. doi: 10.1080/02646838.2025.2485120. Online ahead of print.
- Karaman SC, Unal E, Demir H. Investigation of the effect of fathers' postnatal feelings of security on father-infant attachment. J Pediatr Nurs. 2025 Nov-Dec;85:586-592. doi: 10.1016/j.pedn.2025.09.022. Epub 2025 Sep 27.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-PM-01
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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