Immediate skin-to-skin contact after cesarean to support newborn heart rate variability
Effect of Immediate Skin-to-Skin Contact With the Mother on Heart Rate Variability in Newborns After Cesarean Secton
This project will test whether placing newborns skin-to-skin with their mothers immediately after a planned cesarean helps mothers and babies show higher heart rate variability in the first hours after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana, Ljubljana) |
| Trial ID | NCT07109076 on ClinicalTrials.gov |
What this trial studies
The study will enroll 80 mother–newborn pairs delivered by planned cesarean at 39+ weeks and assign them to immediate direct skin-to-skin contact or routine care. Heart rate variability (beat-to-beat intervals) will be recorded in the first hours after birth for both newborns and mothers as a noninvasive marker of autonomic regulation. The protocol excludes pregnancies with major complications and newborns who require resuscitation at birth. Group comparisons of HRV metrics will determine whether immediate skin-to-skin increases parasympathetic-linked variability after cesarean delivery.
Who should consider this trial
Good fit: Ideal candidates are mother–baby pairs scheduled for a planned cesarean at 39 weeks or later without major pregnancy complications.
Not a fit: Babies who require resuscitation at birth or pregnancies complicated by conditions such as hypertensive disorders or fetal growth restriction are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce immediate post-cesarean stress and improve early autonomic (heart rate) regulation for newborns and their mothers.
How similar studies have performed: Skin-to-skin contact after vaginal birth has been associated with improved newborn regulation, but evidence specifically showing benefits for heart rate variability after cesarean delivery is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana, Ljubljana
- University Medical Center Ljubljana — Ljubljana, Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Miha Lucovnik, MD, PhD
- Email: miha.lucovnik@kclj.si
- Phone: +38615229530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.