NCT07109076 Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton
| NCT ID | NCT07109076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Neonatal Adaptation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * planned cesarean section * gestational age 39 weeks 0/7 or more Exclusion Criteria: * Pregnancy complications (e.g. hypertensive disorders in pregnancy, fetal growth restriction, etc.) * neonatal resuscitation at birth
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07109076 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Neonatal Adaptation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07109076 currently recruiting?
Yes, NCT07109076 is actively recruiting participants. Contact the research team at miha.lucovnik@kclj.si for enrollment information.
Where is the NCT07109076 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07109076 clinical trial?
NCT07109076 is sponsored by University Medical Centre Ljubljana. The trial plans to enroll 80 participants.