Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton

NCT07109076 | Recruiting

• 1 other identifier: 0120-227/2025-2711-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

At birth, both the newborn and the mother experience adaptive stress, which can be measured using objective physiological methods. One of the possible methods is monitoring heart rate variability, which is an indirect indicator of the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. The proposed study will monitor the effect of early skin-to-skin contact on heart rate variability in newborns delivered by cesarean section and their mothers. The researchers hypothesize that newborns and mothers who are provided with immediate direct skin-to-skin contact, compared to the control group receiving standard care, will exhibit higher heart beat-to-beat interval variability in the first hours after birth. This is expected to result from reduced stress and activation of the parasympathetic nervous system. The study will include 80 newborn-mother pairs with a gestational age of 39 weeks or more, delivered via planned cesarean section. Participants will be randomly assigned to a study group (skin-to-skin contact lasting at least 15 minutes after cesarean birth) and a control group (standard care), with 40 newborns in each group. Maternal and neonatal ECG will be monitored for 15 minutes following cesarean birth in both groups. In addition, neonatal ECG will be monitored at 6, 12 and 24 hours postpartum. Time-domain analyses of hearth rate variability will be performed.

Conditions

Neonatal Adaptation

Keywords

heart rate variability; cesarean section; cesarean birth; skin-to-skin contact

Outcome Measures

Primary Outcomes (3)

• Neonatal RMSSD 15 minutes after birth

  RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).

  15 minutes following cesarean birth.

• Neonatal SDNN 15 minutes after birth

  SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).

  15 minutes following cesarean birth

• Neonatal pNN50 15 minutes after birth

  pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.

  15 minutes following cesarean birth

Secondary Outcomes (12)

• Maternal RMSSD 15 minutes after birth

  15 minutes following cesarean birth

• Maternal SDNN 15 minutes after birth

  15 minutes following cesarean birth

• Maternal pNN50 15 minutes after birth

  15 minutes following cesarean birth

• Neonatal RMSSD 6 hours after birth

  6 hours after cesarean birth

• Neonatal SDNN 6 hours after birth

  6 hours after cesarean birth

Other Outcomes (1)

• Neonatal-maternal hearth rate phase synchronisation

  15 minutes after cesarean birth

Study Arms (2)

skin-to-skin contact group

EXPERIMENTAL

Uninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth.

Other: skin-to-skin contact

control group

ACTIVE COMPARATOR

Neonates and mother in this arm will receive routine postnatal care without early skin-to-skin contact. Current routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father.

Other: routine care

Interventions

skin-to-skin contact OTHER

Uninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth.

skin-to-skin contact group

routine care OTHER

Current routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father.

control group

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• planned cesarean section
• gestational age 39 weeks 0/7 or more

You may not qualify if:

• Pregnancy complications (e.g. hypertensive disorders in pregnancy, fetal growth restriction, etc.)
• neonatal resuscitation at birth

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

Central Study Contacts

Miha Lucovnik, MD, PhD

CONTACT

+38615229530; miha.lucovnik@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Miha Lucovnik, MD, PhD

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 7, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

SL (1)