Trials / Not Yet Recruiting
Not Yet RecruitingNCT07410754
Effect of Combined Skin-to-Skin Contact and Kangaroo Care on Breastfeeding and Bonding in Cesarean-Born Newborns
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Istanbul University - Cerrahpasa · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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. 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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-06-01
- Completion
- 2026-07-01
- First posted
- 2026-02-13
- Last updated
- 2026-02-13
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07410754. Inclusion in this directory is not an endorsement.