Clinical trial Recruiting at 1 site Interventional Ages 0 and up

Immediate skin-to-skin contact after cesarean to support newborn heart rate variability

Official title: Effect of Immediate Skin-to-Skin Contact With the Mother on Heart Rate Variability in Newborns After Cesarean Secton

Run by University Medical Centre Ljubljana · NCT07109076 · Data updated 2026-11-12

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.

More Neonatal Adaptation trials

Quick facts

Study typeInterventional
Ages0 Years and up
SexAll
Enrollment80 (estimated)
SponsorUniversity Medical Centre Ljubljana
Academic / other
Locations1 site (Ljubljana, Ljubljana)
StatusRecruiting
StartedMarch 1, 2026
Main results expectedDecember 1, 2026
Study endsDecember 2, 2026
Registry record updatedMarch 27, 2026
Trial IDNCT07109076 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are mother–baby pairs scheduled for a planned cesarean at 39 weeks or later without major pregnancy complications.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University Medical Center Ljubljana
    Ljubljana, Ljubljana, Slovenia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.