Evaluation of the Effect of Immediate and Early Skin-to-Skin Contact After Cesarean on Maternal and Neonatal Parameters in the First 24 Hours: A Quasi-Experimental Study

NCT07531758 | Completed DMC

• 1 other identifier: 77082166-302.08.01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study was carried out as a quasi-experimental study to determine the effects of immediate and early skin-to-skin contact (SSC) applied between mother and newborn after cesarean on breastfeeding, anxiety, bleeding and newborn health in the first 24 hours. The application of the study carried out in the cesarean operating room and gynecology services of a private hospital. The required institutional permission and ethics committee approval was received. The sample consisted of 92 mother-infant couples totally, 30 of whom selected to immediate skin-to-skin contact (ISSC), 29 of whom selected to early skin-to-skin contact (ESSC), 33 of whom selected to the control group. The data was collected using Prenatal and postnatal data collection form, Breastfeeding Assessment Tool Scale (IBFAT), The State-Trait Anxiety Inventory and Maternal and newborn follow-up chart for the first 24 hours postpartum. In ISSC group, skin contact was applied within the first 5 minutes after cesarean, and applied to the ESSC group within the first hour after cesarean, and skin contact lasted 40 minutes. The data stored in the SPSS 24 program. In the analysis of the data, Independent Sample-t test, ANOVA test, Paired Sample-t test, Mann-Whitney U test, Kruskal-Wallis H test, Wilcoxon test, Bonferroni correction, Pearson and Spearman correlation coefficient and χ2 test used.

Conditions

Ssc; Cesarean Birth; Neonate; Breastfeeding; Anxiety; Maternal Blood Loss

Keywords

Immediate skin-to-skin contact; early skin-to-skin contact; breastfeeding; neonate; anxiety; maternal hemorrhage

Outcome Measures

Primary Outcomes (8)

• Breastfeeding Assessment Tool Scale (IBFAT)

  IBFAT administered to women at the first beastfeeding and postpartum 24th hour to assess breastfeed success.

  Within 24 hours after cesarean section

• The State-Trait Anxiety Inventory (STAI)

  Mothers asked to fill out STAI at postpartum 2nd hour for all groups to assess the anxiety levels.

  Postpartum 2nd hour

• Maternal hemorrhage

  Total Maternal hemorrhage (grams) amounts were measured in all groups at 24 hours postpartum.

  Within 24 hours after cesarean section

• Body temperature of newborns

  Body temperatures (°C) of newborns were measured with thermometer.

  Within 24 hours after cesarean section

• Heart rates of newborns

  Heart rates per minute of newborns were measured with pulse oximeter.

  Within 24 hours after cesarean section

• Peripheral oxygen saturation of newborns

  Peripheral oxygen saturation (%) of newborns were measured with pulse oximeter.

  Within 24 hours after cesarean section

• Respiratory rate of newborns

  Respiratory rate per minute of newborns were measured.

  Within 24 hours after cesarean section

• Blood glucose levels of newborns

  Blood glucose levels (mg/dL) of the newborns were measured with glocometer.

  Postpartum 2nd hour

Secondary Outcomes (1)

• Newborns' weight loss

  Postpartum 24th hour

Study Arms (1)

Skin to skin contact

EXPERIMENTAL

Behavioral: skin to skin contact

Interventions

skin to skin contact BEHAVIORAL

skin to skin contact applied as an immediate and early

Skin to skin contact

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For mothers:
• Scheduled cesarean section before spontaneous contractions begin
• Receiving epidural or spinal anesthesia
• Nulliparous
• Singleton pregnancy
• Age 18 and over
• Gestational age 37-42 weeks
• Literacy
• No known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
• No contraindications to breastfeeding (no human T-cell lymphotropic virus (HTLV-1), human immunodeficiency virus (HIV), or active tuberculosis) Speaking Turkish
• For neonates:
• Birth weight 2500-4000 gr.
• Being between 7 and 5 minutes old
• Having an APGAR score of 7 or higher at 1 and 5 minutes
• Not having any health problems or congenital anomalies

You may not qualify if:

• Mothers whose general condition and vital signs deteriorate during skin-to-skin contact
• Neonates who experience respiratory and circulatory problems during skin-to-skin contact
• Neonates admitted to intensive care within the first 24 hours
• Mothers who do not accumulate pads or diapers

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Ankara private hospital

Ankara, 06660, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Mental Disorders

Study Officials

• Ayten ŞENTÜRK ERENEL, PhD, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: April 15, 2026
• Study Start: September 20, 2018
• Primary Completion: November 16, 2019
• Study Completion: May 15, 2020
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)