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

Study acronym: HRV-SCENE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2026 to Dec 1, 2026
    • Start date changed from estimate of Sep 1, 2025 to Mar 1, 2026
    • Study completion date: Apr 2, 2026 to Dec 2, 2026
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07109076
Lead Sponsor University Medical Centre Ljubljana
Conditions
(from sponsor)
Neonatal Adaptation
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov