Actively Recruiting
Effect of Immediate Skin-to-Skin Contact With the Mother on Heart Rate Variability in Newborns After Cesarean Section
Led by University Medical Centre Ljubljana · Updated on 2026-03-27
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how early skin-to-skin contact affects heart rate variability (HRV) in newborns delivered by planned cesarean section and their mothers. The study focuses on the balance of the autonomic nervous system, which can be measured by HRV as an indicator of stress and physiological adaptation after birth. This randomized trial aims to see if immediate skin-to-skin contact reduces stress and improves autonomic function compared to standard care. The study involves 80 mother-newborn pairs with a gestational age of 39 weeks or more, randomly assigned to either a skin-to-skin contact group or a control group receiving routine postnatal care. In the intervention group, uninterrupted skin-to-skin contact will begin immediately after birth and last at least 15 minutes. Both groups will have maternal and neonatal electrocardiographic (ECG) monitoring for 15 minutes after birth, with additional neonatal ECG recordings at 6, 12, and 24 hours postpartum to analyze HRV. Participants will undergo ECG monitoring to assess heart rate variability measures such as RMSSD, SDNN, and pNN50 at multiple time points after birth. The study will evaluate both neonatal and maternal HRV as indicators of stress and autonomic nervous system balance. The total follow-up includes immediate post-birth monitoring and assessments up to 24 hours after birth, helping researchers understand the impact of skin-to-skin contact on neonatal adaptation following cesarean delivery.
CONDITIONS
Brief Title
Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned cesarean section
- Gestational age of 39 weeks 0/7 or more
You will not qualify if you...
- Pregnancy complications such as hypertensive disorders or fetal growth restriction
- Neonatal resuscitation required at birth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At birth and first 15 minutes postpartum
Participants undergo planned cesarean section and are assigned to either immediate skin-to-skin contact or routine postnatal care following birth.
1 visit (in-person) during delivery and immediate postpartum period
Duration - 24 hours after birth
Neonatal heart rate variability is monitored through ECG at 6, 12, and 24 hours after birth to assess autonomic function.
3 visits (in-person) at 6, 12, and 24 hours postpartum
Trial Site Locations
Total: 1 location
1
University Medical Center Ljubljana
Ljubljana, Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
M
Miha Lucovnik, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here