NCT07304037

Brief Summary

Skin-to-skin contact (STSC) initiated within the first hour after birth is a fundamental practice that supports both the mother's and the newborn's physiological and psychological adaptation (Çelik \& Kök, 2022). The World Health Organization recommends at least 90 minutes of uninterrupted SKC immediately after birth and defines this practice as a mandatory component of care under the Baby-Friendly Hospital Initiative (World Health Organization, 2024; Abdulghani et al., 2018; Sharma, 2016). The positive effects of TTT on maintaining the newborn's temperature, glucose regulation, physiological stability, and mother-infant bonding have been proven (Sezici \& Yiğit, 2020; Safar et al., 2018). In addition, it has been reported that it can shorten the third stage of labor by increasing maternal oxytocin release and reduce maternal stress and anxiety (Püsküllüoğlu et al., 2022; Harati Kabir et al., 2024). In the study, mothers in the intervention group will receive one hour of uninterrupted TTT immediately after delivery; routine midwifery care will continue in the control group. In both groups, maternal pain levels, birth satisfaction, and vital signs (body temperature, oxygen saturation, heart rate, and blood pressure) will be assessed immediately after delivery, and at 30, 60, and 90 minutes. The sample size was calculated using GPower, and a total of 68 participants (34 in each group) will be included in the study. Inclusion criteria include women aged 18 years or older who have had a full-term vaginal delivery and have a single, uncomplicated pregnancy. The data collection tools used will be the Demographic Information Form and the Visual Analog Scale (VAS). The findings of the study are expected to enhance the quality of midwifery care by supporting the integration of TTT into clinical practice in early postpartum care.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1 day

First QC Date

December 12, 2025

Last Update Submit

December 24, 2025

Conditions

Keywords

maternal vital signsskin-to-skin contactbirth satisfactionMaternal outcomeslabor pain

Outcome Measures

Primary Outcomes (2)

  • Visuel Analog Scale -Pain

    Min: 0- Max:10

    At 30, 60, and 90 minutes after birth

  • Visuel Analog Scale- Birth satisfaction

    Min:0-Max:10

    At 30, 60, and 90 minutes after birth

Study Arms (2)

Experimental Group

EXPERIMENTAL

Immediately after birth, skin-to-skin contact is maintained continuously for one hour. Pain levels, birth satisfaction levels, and maternal vital signs (body temperature, oxygen saturation, heart rate, and blood pressure) are assessed at 30, 60, and 90 minutes postpartum.

Procedure: A solid hour of skin-to-skin contact

Control Group

NO INTERVENTION

Following delivery, routine midwifery care is provided, and immediately after birth, at 30, 60, and 90 minutes, pain levels, satisfaction with the birth, and maternal physiological findings (body temperature, oxygen saturation, heart rate, and blood pressure) are assessed.

Interventions

Immediately after birth, skin-to-skin contact is maintained for one hour without interruption. Pain levels, birth satisfaction levels, and maternal vital signs (body temperature, oxygen saturation, heart rate, and blood pressure) are assessed at 30, 60, and 90 minutes postpartum.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily agree to participate in the study
  • Be able to read, understand, and write in Turkish
  • Be 18 years of age or older
  • Have given birth vaginally
  • Have given birth to a single baby
  • Be at term (between 38-42 weeks of gestation)
  • Have given birth vaginally in vertex presentation
  • Estimated fetal weight between 2500-4000 grams
  • Not having received any analgesia or anesthesia to relieve pain and fatigue during labor
  • Having a pregnancy without maternal or fetal complications

You may not qualify if:

  • Multiple pregnancies
  • High-risk pregnancies with complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (7)

  • Abdulghani N, Edvardsson K, Amir LH. Worldwide prevalence of mother-infant skin-to-skin contact after vaginal birth: A systematic review. PLoS One. 2018 Oct 31;13(10):e0205696. doi: 10.1371/journal.pone.0205696. eCollection 2018.

  • Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20.

  • Safari K, Saeed AA, Hasan SS, Moghaddam-Banaem L. The effect of mother and newborn early skin-to-skin contact on initiation of breastfeeding, newborn temperature and duration of third stage of labor. Int Breastfeed J. 2018 Jul 16;13:32. doi: 10.1186/s13006-018-0174-9. eCollection 2018.

  • Kabir FH, Razavinia F, Keshavarz M, Mousavi SS, Haghani H. Effect of Companion Presence during Skin-to-Skin Contact on Maternal Anxiety: A Randomized Clinical Trial. Indian Pediatr. 2024 Mar 15;61(3):230-236.

  • Püsküllüoğlu, B., Göker, A. & Kosova, F. The effect of skin-to-skin contact on the expulsion time of the placenta and delivery hormones. DEU Tıp Dergisi, 2022, 36(3), 237-242. https://doi.org/10.18614/deutip1230581

    RESULT
  • Sezici E, Yigit D. The Effect of Skin-to-Skin Contact on Maternal Anxiety, Heart Rate, and Oxygen Saturation during the Vaccination of One-Month-Old Infants. Compr Child Adolesc Nurs. 2020 Dec;43(4):410-420. doi: 10.1080/24694193.2020.1721614. Epub 2020 Feb 19.

  • Çelik, İ. & Kök, G. Examination of nurses' and midwives' knowledge and attitudes regarding early skin-to-skin contact between mother and newborn. Istanbul Development University Journal of Health Sciences, 2022, 17, 558-574.

    RESULT

Related Links

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yasemin Dinçel

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Assistant

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

May 12, 2025

Primary Completion

May 13, 2025

Study Completion

April 15, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations