Investigation of the Effects of Early Skin-to-Skin Contact on Mother and Baby in Cesarean Births

NCT07111949 | Recruiting DMC

• 1 other identifier: Nursing 12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of cesarean birth continues to increase in the world and in our country. As with all surgeries, the risks of cesarean birth include the possibility of bleeding and infection, prolonged recovery time after birth, delays in initiating breastfeeding and skin-to-skin contact (SSC), and increased likelihood of complications in future pregnancies. While many hospitals apply SSC after normal births, it is known that the number of hospitals that apply SSC in the operating room after cesarean birth is very few. Factors that prevent the initiation of SSC after cesarean birth include the effect of the current operating room culture, the physiological evaluation process of the baby after birth, the presence of procedures such as measuring body weight, aspiration, and Apgar score evaluation. Since the mother and baby are separated after cesarean birth, the mother's initiation of breastfeeding in the first hour of life may be delayed, and the duration of exclusive breastfeeding may be shortened. The 90-minute uninterrupted skin-to-skin contact during which the baby is dried and placed directly on the mother's bare chest after birth maximizes the chance that babies are physically ready to breastfeed. Although there are studies showing the benefits of SSC application in the operating room such as breastfeeding rates, maintaining the body temperature of the newborn, reducing maternal stress levels, and increasing oxytocin levels, a limited number of studies have been reached in the literature using SSC application guidelines developed to ensure the sustainability of SSC application in the operating room, post-op care unit, and obstetrics clinic. The first contribution of this planned study to the literature will be to standardize SSC application with SSC checklists prepared for use in the cesarean operation room, post-op care unit, and obstetrics ward based on SSC application guidelines. As a second contribution, considering the conditions of the health institution where the study will be conducted, the effects of starting SSC as early as possible and applying it in the cesarean operation room, post-op care unit, and obstetrics ward on the stress level of newborns, sucking success, and pain and salivary cortisol (stress) levels of mothers will be evaluated.

Conditions

Skin-to-skin Contact

Keywords

skin-to-skin contact; newborn; mother; stress; cesarean delivery; pain

Outcome Measures

Primary Outcomes (2)

• Stress levels and sucking success of newborns

  Newborn Stress Scale The scale items are grouped into eight subgroups using a three-point Likert scale, including facial expression, skin color, respiration, activity level, soothability, muscle tone, extremities, and posture. Each subgroup is scored on a scale of 0-2 points, with a minimum score of 0 and a maximum score of 16. As the score increases, the infant's stress level increases.

  From birth to the first 24 hours of life

• Pain and salivary cortisol (stress) levels of mothers

  The level of pain experienced by mothers will be assessed using a Visual Analog Scale (VAS). VAS is frequently used to measure subjective parameters. VAS is a 10 cm ruler where "0" represents "no pain" and '10' represents "very severe pain." The patient is instructed to mark the appropriate point on the line corresponding to the intensity of their pain. The distance from the lowest VAS level to the patient's mark is measured with a ruler in centimeters (cm) or millimeters (mm) to obtain the numerical value of the patient's pain intensity. Pain also causes stress. Saliva samples, a noninvasive biomarker, will be collected to determine the stress levels of mothers.

  From before transfer to the operation room until 1 hour after transfer to the ward room after birth.

Secondary Outcomes (1)

• Satisfaction levels o mothers regarding SSC application after cesarean delivery with spinal anesthesia

  From the first SSC application until 24 hours after birth

Study Arms (2)

SSC Group 1 (Operation room)

ACTIVE COMPARATOR

Skin-to-skin contact (SSC) will be initiated in the operation room, will continue in the post-op care room, while SSC continues, the mother and baby will be transferred to the ward room, and SSC will be continued in the ward room.

Other: SSC Group 1 (Operation room)

SSC Group 2 (Post-operation room)

ACTIVE COMPARATOR

Skin-to-skin contact (SSC) will be initiated in the post-operative care unit, SSC will not be uninterrupted, SSC will be continued in the ward room.

Other: SSC Group 2 (Post-operation room)

Interventions

SSC Group 1 (Operation room) OTHER

Salivary cortisol sampling from mothers, pain assessment (VAS), and measurement of physiological findings will be done at the following 3 measurement times. (1)Before transfer to the operating room (OR) (2)1 hour (h) after admission to the post-op room (PR) (3)at least 1 h after admission to the maternity ward (MW) The stress levels of the newborns will be assessed using the "Neonatal Stress Scale" at the following 4 measurement times, the heart rate and O2 saturation will be measured and recorded. 1. At least 5 min after the initiation of SSC in the OR 2. During the Hep-B vaccination in the PR 3. At least 30 min after SSC after admission to the MW 4. At least 24 h after birth in the MW, at least 30 min after SSC. The success of the newborn sucking will be assessed using the LATCH at the following 3 measurement times. (1) At least 5 min after the initiation of SSC in the OR (2)At least 1 h after admission to the MW, during SSC (3)At least 24 h after birth in the MW during SSC.

Also known as: SSC1

SSC Group 1 (Operation room)

SSC Group 2 (Post-operation room) OTHER

SC sampling from mothers, pain assessment (VAS), and measurement of physiological findings will be done at the following 3 measurement times. (1)Before transfer to the OR (2)1 hour (h) after admission to the PR (3)At least 1 h after admission to the MW. The stress levels of newborns will be assessed using the "Neonatal Stress Scale" at the following 4 measurement times, and heart rate and oxygen saturation will be measured and recorded. (1)At least 5 min after birth under radiant heater in the baby care room (BCR) (2)At least 10 min after being taken to the BCR during Hep-B vaccination under radiant heater (3)At least 5 min after being admitted to the maternity ward after SSC (4)5 min after being held in the mother's arms Newborn sucking success will be assessed using LATCH at the following 3 measurement times. (1)At least 5 min after starting SSC in the post-op care unit (2)During SSC after being admitted to the MW (3)At least 24 h after being held in the mother's arms in the MW.

Also known as: SSC2

SSC Group 2 (Post-operation room)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women with gestational age 37 and above
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mothers;
• Planning a cesarean section with spinal anesthesia
• Being between the ages of 18-45
• Having a singleton pregnancy
• Being between the gestational age of 37-40 weeks
• Not having any known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
• Agreeing to participate in the study
• Having stable general conditions and vital signs before the skin-to-skin contact procedure
• Residing in Kütahya
• Newborns (0-28 days)
• Having a gestational age between 37-40 weeks
• Having a birth weight between 2500-4500 grams
• Apgar score ≥ 7 per minute
• No health problems, anomalies or congenital diseases
• No conditions that prevent sucking such as frenulum (tongue tie) or palate problems

You may not qualify if:

• Caesarean births performed with general anesthesia
• Normal births

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University

Merkez, Kütahya, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Betül Yavuz, PhD

CONTACT

+90 274 260 00 43; betul.yavuz@ksbu.edu.tr

Meltem Çatalbaş, PhD

CONTACT

+90 274 260 00 43; meltem.çatalbas@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the study, if the condition of mothers and newborns is stable immediately after the cesarean section in group 1 (SSC1), SSC will be applied as continuously as possible in the cesarean operation room, post-op care unit and ward room. In group 2 (SSC2), if the condition of mothers and newborns is stable after the cesarean section, SSC will be started in the post-op care unit and SSC will be continued in the ward room after the mother and baby are transferred to the maternity ward.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: August 8, 2025
• Study Start: March 19, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-03

Locations

TU (1)