Maternal Vital SignsNCT07304037
The Effect of Skin-to-Skin Contact Applied in the Early Postpartum Period on Maternal Pain, Birth Satisfaction, and Maternal Vital Signs Dynamics
A study testing A solid hour of skin-to-skin contact in people with Maternal Vital Signs and Skin-to-skin Contact, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Vital Signs, Skin-to-skin Contact, Birth Satisfaction
- What is being tested?
- A solid hour of skin-to-skin contact
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2025to 15 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- Multiple pregnancies
- High-risk pregnancies with complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University Cerrahpaşa
Istanbul, 34500
About this study
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.
Read more
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.
Read the detailed description
H1: There is a difference in pain scores measured using the Visual Analog Scale (VAS) between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group immediately after birth, at 30, 60, and 90 minutes.
H1: There is a difference in birth satisfaction scores measured using the Visual Analog Scale (VAS) between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group immediately after birth, at 30, 60, and 90 minutes.
H1: There is a difference between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group in terms of maternal body temperature, oxygen saturation, heart rate, and blood pressure measurements taken immediately after birth and at 30, 60, and 90 minutes.
- Being tested
- A solid hour of skin-to-skin contact
- Keywords
- maternal vital signs, skin-to-skin contact, birth satisfaction, Maternal outcomes, labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A solid hour of skin-to-skin contactProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel Analog Scale -Pain
Min: 0- Max:10
Measured: At 30, 60, and 90 minutes after birth
Visuel Analog Scale- Birth satisfaction
Min:0-Max:10
Measured: At 30, 60, and 90 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start12 May 2025
- Primary completion13 May 2025
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maternal Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Dincel, Istanbul University - Cerrahpasa
- Investigators
- Yasemin Dinçel, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304037
- Sponsor's protocol ID
- 2025/332
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30379859Sharma 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.
PubMed 27917213Safari 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.
PubMed 30026787Kabir 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.
PubMed 38469838Püsküllüoğlu, 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
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.
PubMed 32073934Çelik, 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.