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RECRUITING
NCT07109076
NA

Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton

Sponsor: University Medical Centre Ljubljana

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03-01

Completion Date

2026-12-02

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

OTHER

skin-to-skin contact

Uninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth.

OTHER

routine care

Current routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father.

Locations (1)

University Medical Center Ljubljana

Ljubljana, Ljubljana, Slovenia