Clinical Trial

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

Study acronym: HRV-SCENE
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-30.
Status change: Not Yet Recruiting → Recruiting 2026-03-23
Trial Details
NCT Number NCT07109076
Lead Sponsor University Medical Centre Ljubljana
Conditions Neonatal Adaptation
Enrollment 80 participants
Start Date 2026-03-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-27