The Effect of Skin-to-skin Contact Between Mother and Newborn

NCT06827522 | Not Yet Recruiting

• 1 other identifier: 2024/224
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A 2016 Cochrane Review shows that skin-to-skin contact promotes breastfeeding and strengthens mother-infant bonding. For the mother, skin-to-skin contact was found to promote early separation of the placenta, reduce postpartum haemorrhage, increase breastfeeding self-efficacy, reduce stress levels and promote oxytocin release. For the infant, it has been revealed that it provides important benefits such as decreased postnatal stress, improved thermoregulation, shortened crying time and increased breastfeeding success. In line with this information, it is hypothesised that Galvanic Skin Response can be used to objectively evaluate the psychological and mental effects of early skin-to-skin contact on the mother and newborn after birth. The findings of this study will contribute to clinical practice by providing scientific evidence for neonatal care.

Conditions

Galvanic Skin Response; Skin to Skin Contact

Keywords

Spinal anesthesia; General anesthesia; Skin to skin contact; Newborn

Outcome Measures

Primary Outcomes (1)

• Galvanic Skin Response

  Skin To Skin contact of the newborn with the mother affects the Galvanic Skin Response.

  Effects of skin-to-skin contact with in 5 minutes after birth

Study Arms (2)

General Anesthesia

EXPERIMENTAL

Pregnant women who will have a cesarean section under general anesthesia.

Procedure: Birth Under General Anesthesia

Spinal Anestesia

EXPERIMENTAL

Pregnant women who will have a cesarean section under spinal anesthesia.

Procedure: Birth Under Spinal Anesthesia

Interventions

Birth Under General Anesthesia PROCEDURE

Before anaesthesia, GSR electrodes will be connected and signal recording will be started. After caesarean section, the newborn will be evaluated and GSR signals will be recorded again after the mother wakes up by providing skin-to-skin contact.

General Anesthesia

Birth Under Spinal Anesthesia PROCEDURE

GSR electrodes will be connected before anaesthesia, and since the mother will be conscious during caesarean section, the newborn will have skin-to-skin contact with the mother immediately after birth. During this process, GSR signals of the mother and the baby will be recorded.

Spinal Anestesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnancy between 37-40 weeks
• Elective caesarean section
• Having a singleton pregnancy

You may not qualify if:

• Preterm labour under 37 weeks of gestation
• Those with known systemic diseases
• Those with known fetal anomalies
• Pregnant women who will give birth normally
• Multiple pregnancies

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, Turkey (Türkiye)

Location

Central Study Contacts

Fatma Özdemir

CONTACT

+905302859400; dr.ftmozdemir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Model Details: In the study, 100 volunteers (n=50 general anesthesia, n=50 spinal anaesthesia) will undergo caesarean section, and the choice of anaesthesia will be made with the consent of the patient. The type of anesthesia will evaluate the effects of skin-to-skin contact on the mother and baby.. Prenatal GSR electrodes will be connected and signal recordings will be obtained from mother and baby, and the physiological effects of skin-to-skin contact will be analysed. APGAR score (Activity, pulse, grimace, apperarance, respiration 0-10), cord pH, birth weight and neonatal follow-up data will be recorded. GSR signals will be recorded and filtered with BIOPAC, features will be extracted and time and frequency analyses will be performed. Classification will be performed with artificial neural networks and deep learning. The results will be evaluated with statistical tests and the effect of anaesthesia type and skin-to-skin contact on mother-infant will be investigated.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: February 20, 2025
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

TU (1)