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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

planned cesarean section

gestational age 39 weeks 0/7 or more

Disqualifiers

Pregnancy complications (e.g. hypertensive disorders in pregnancy, fetal growth restriction, etc.)

neonatal resuscitation at birth

Trial design

Design model

Parallel

Treatments tested in this trial

  • skin-to-skin contact

    Other intervention

    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.

  • routine care

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: skin-to-skin contact groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neonatal RMSSD 15 minutes after birth

RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).

Time frame
15 minutes following cesarean birth.
2

Neonatal SDNN 15 minutes after birth

SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).

Time frame
15 minutes following cesarean birth
3

Neonatal pNN50 15 minutes after birth

pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.

Time frame
15 minutes following cesarean birth

Secondary outcomes

1

Maternal RMSSD 15 minutes after birth

RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).

Time frame
15 minutes following cesarean birth
2

Maternal SDNN 15 minutes after birth

SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).

Time frame
15 minutes following cesarean birth
3

Maternal pNN50 15 minutes after birth

pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.

Time frame
15 minutes following cesarean birth
4

Neonatal RMSSD 6 hours after birth

RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).

Time frame
6 hours after cesarean birth

Other outcomes

1

Neonatal-maternal hearth rate phase synchronisation

Phase synchronisation between neonatal and maternal heart rate in the first 15 minutes after birth will be expressed as a phase synchronisation index (values between 0 (no synchronisation) and 1 (perfect synchronisation)).

Time frame
15 minutes after cesarean birth

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