NCT07410754

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 8, 2026

Last Update Submit

February 8, 2026

Conditions

Keywords

Skin-to-Skin ContactCesarean BirthBreastfeeding OutcomesMaternal AttachmentPaternal Attachment

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Paternal Postnatal Attachment Scale (PPAS)

    3 months

Other Outcomes (1)

  • Bristol Breastfeeding Assessment Tool (BBAT)

    3 months

Study Arms (2)

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.

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.

Interventions

InterventionBEHAVIORAL

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.

Consecutive Skin-to-Skin Contact Group ( İntervention )

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeytinburnu Avrasya Hospitol

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 40086104BACKGROUND
  • Abiha 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.

    PMID: 38054187BACKGROUND
  • Moore 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.

    PMID: 41120189BACKGROUND
  • Huang 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.

    PMID: 36002214BACKGROUND
  • 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.

    PMID: 40150891BACKGROUND
  • 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.

    PMID: 41016224BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Feeding

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • sevil İnal, PhD

    Cerrahpaşa University, Faculty of Health Sciences, Midwifery Department

    STUDY CHAIR
  • Paria Mohammadiasl, MSc

    Zeytinburu Avrasya Hospital / Cerrahpaşa University, Midwifery Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paria Study Coordinator / Midwife, MSc

CONTACT

Sevil Professor/Advisor, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not applied in this study because the skin-to-skin contact intervention cannot be blinded to participants or researchers.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paria MOHAMMADİASL

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations