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

Recruiting now · Not applicable

Conditions studied: Neonatal Adaptation

In brief

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.

Key facts

Study ID

NCT07109076

Run by

University Medical Centre Ljubljana

People needed

80

Starts

2026-03-01

Expected to finish

2026-12-02

Last updated by the study team

2026-03-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University Medical Center Ljubljana — Ljubljana, Ljubljana, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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