Actively Recruiting
Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton
Led by University Medical Centre Ljubljana · Updated on 2026-03-27
80
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
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Trial Site Locations
Total: 1 location
1
University Medical Center Ljubljana
Ljubljana, Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
M
Miha Lucovnik, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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