Actively Recruiting

Phase Not Applicable
Age: 0Years +
All Genders
NCT07109076

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

Led by University Medical Centre Ljubljana · Updated on 2026-03-27

80

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned cesarean section
  • Gestational age of 39 weeks 0/7 or more
Not Eligible

You will not qualify if you...

  • Pregnancy complications such as hypertensive disorders or fetal growth restriction
  • Neonatal resuscitation required at birth

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Medical Center Ljubljana

Ljubljana, Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

M

Miha Lucovnik, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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