BreastfeedingSSC-CSNCT07410754
Effect of Combined Skin-to-Skin Contact and Kangaroo Care on Breastfeeding and Bonding in Cesarean-Born Newborns
A study testing Intervention in people with Breastfeeding and Skin to Skin Contact, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of consecutive skin-to-skin contact applied by the mother and father on breastfeeding parameters and parent-infant bonding in babies born by cesarean section. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Skin to Skin Contact, Cesarean Birth
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2026to Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Zeytinburnu Avrasya Hospitol
Istanbul, Istanbul
Paria Study Coordinator / Midwife, MSc, +905526018494, paria.mohammadiasl@ogr.iuc.edu.tr
Sevil professor/Advisor, PhD, +90 212 866 3700 ext. 43162, sevil@iuc.edu.tr
About this study
Official title: 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
This randomized controlled study aims to evaluate the effect of consecutive skin-to-skin contact applied by the mother and father on breastfeeding parameters and parent-infant bonding in babies born by cesarean section. The study includes two groups: an intervention group receiving consecutive skin-to-skin contact by the father followed by the mother, and a control group receiving routine postnatal care. Breastfeeding success and parental bonding will be assessed using validated measurement tools during the early postnatal period and follow-up.
Read the 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.
- Conditions
- Breastfeeding, Skin to Skin Contact, Cesarean Birth, Kangaroo Care
- Being tested
- Intervention
- Keywords
- Skin-to-Skin Contact, Cesarean Birth, Breastfeeding Outcomes, Maternal Attachment, Paternal Attachment
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive Skin-to-Skin Contact Group ( İntervention ) | Experimental | 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. Receives: Behavioral: Intervention |
| Routine Care Group ( Control ) | No intervention | Newborns in this group receive routine postpartum and newborn care according to the hospital's standard clinical protocol following cesarean delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Postnatal Attachment Scale (MPAS)
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.
Measured: 3 months
Secondary outcomes (1)
Paternal Postnatal Attachment Scale (PPAS)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-group interventional study conducted with two arms. The intervention group receives consecutive skin-to-skin contact applied first by the father and then by the mother following cesarean delivery, while the control group receives routine postpartum care. The two groups are followed concurrently and outcomes related to breastfeeding parameters and parent-infant bonding are compared prospectively.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paria Mohammadiasl, Istanbul University - Cerrahpasa
- Investigators
- sevil İnal, PhD, Study chair, Cerrahpaşa University, Faculty of Health Sciences, Midwifery DepartmentParia Mohammadiasl, MSc, Principal investigator, Zeytinburu Avrasya Hospital / Cerrahpaşa University, Midwifery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410754
- Sponsor's protocol ID
- MD-PM-01
- Acronym
- SSC-CS
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40086104Abiha U, Banerjee DS, Mandal S. Demystifying non-invasive approaches for screening jaundice in low resource settings: a review. Front Pediatr. 2023 Nov 20;11:1292678. doi: 10.3389/fped.2023.1292678. eCollection 2023.
PubMed 38054187Moore ER, Brimdyr K, Blair A, Jonas W, Lillieskold S, Svensson K, Ahmed AH, Bastarache LR, Crenshaw JT, Giugliani ERJ, Grady JE, Zakarija-Grkovic I, Haider R, Hill RR, Kagawa MN, Mbalinda SN, Stevens J, Takahashi Y, Cadwell K. Immediate or early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2025 Oct 22;10(10):CD003519. doi: 10.1002/14651858.CD003519.pub5.
PubMed 41120189Huang Y, Chen L, Wang X, Zhao C, Guo Z, Li J, Yang F, Cai W. Maternal knowledge, attitudes and practices related to neonatal jaundice and associated factors in Shenzhen, China: a facility-based cross-sectional study. BMJ Open. 2022 Aug 24;12(8):e057981. doi: 10.1136/bmjopen-2021-057981.
PubMed 36002214Zarei 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.
PubMed 40150891Karaman 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.
PubMed 41016224