Skin-to-skin ContactNCT07111949
Investigation of the Effects of Early Skin-to-Skin Contact on Mother and Baby in Cesarean Births
A study testing SSC Group 1 (Operation room) and SSC Group 2 (Post-operation room) in people with Skin-to-skin Contact, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin-to-skin Contact
- What is being tested?
- SSC Group 1 (Operation room) and SSC Group 2 (Post-operation room)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2025to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
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- 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
- 1-5. 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
Who cannot join
- Caesarean births performed with general anesthesia
- Normal births
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University
Merkez, Kütahya, 43100
About this study
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.
Read more
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.
Read the detailed description
The main purpose of the proposed study is to evaluate the effect of SSC initiated in different units of the hospital after cesarean delivery with spinal anesthesia on the stress level of newborns, sucking success, pain and salivary cortisol (stress) levels of mothers and physiological parameters of mothers and babies.
The secondary purpose of the study is to evaluate the satisfaction levels of mothers regarding the SSC application initiated in different units of the hospital after cesarean delivery.
Hypotheses of the Study H1: Early initiated SSC is more effective than late initiated SSC in reducing the pain level of mothers after cesarean deliveries.
H2: Early initiated SSC is more effective than late initiated SSC in reducing the salivary cortisol level of mothers after cesarean deliveries.
H3: Early initiated SSC is more effective than late initiated SSC in reducing the stress level of newborns after cesarean deliveries.
H4: Early initiated SSC is more effective than late initiated SSC on the sucking success of newborns after cesarean deliveries.
H5: Early initiation of SSC is more effective than late initiation of SSC in increasing the satisfaction level of mothers after cesarean births.
- Conditions
- Skin-to-skin Contact
- Being tested
- SSC Group 1 (Operation room), SSC Group 2 (Post-operation room)
- Keywords
- skin-to-skin contact, newborn, mother, stress, cesarean delivery, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSC Group 1 (Operation room)Other
Also called SSC1
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.
- At least 5 min after the initiation of SSC in the OR
- During the Hep-B vaccination in the PR
- At least 30 min after SSC after admission to the MW
- 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.
SSC Group 2 (Post-operation room)Other
Also called SSC2
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: SSC Group 2 (Post-operation room) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Mothers will be asked to rate their satisfaction with skin-to-skin contact on a scale of 0 to 10.
Measured: From the first SSC application until 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start19 Mar 2025
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin-to-skin ContactStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111949
- Sponsor's protocol ID
- Nursing 12
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be shared by the corresponding author if requested by the journal editorship in which the study was published.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Early Skin-to-Skin Contact on Mother and Baby in Cesarean Births
- ClinicalTrials.gov ID
- NCT07111949
- Acronym / sponsor ID
- Nursing 12
- Conditions
- Skin-to-skin Contact
- Keywords
- skin-to-skin contact, newborn, mother, stress, cesarean delivery, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main purpose of the proposed study is to evaluate the effect of SSC initiated in different units of the hospital after cesarean delivery with spinal anesthesia on the stress level of newborns, sucking success, pain and salivary cortisol (stress) levels of mothers and physiological parameters of mothers and babies.
The secondary purpose of the study is to evaluate the satisfaction levels of mothers regarding the SSC application initiated in different units of the hospital after cesarean delivery.
Hypotheses of the Study H1: Early initiated SSC is more effective than late initiated SSC in reducing the pain level of mothers after cesarean deliveries.
H2: Early initiated SSC is more effective than late initiated SSC in reducing the salivary cortisol level of mothers after cesarean deliveries.
H3: Early initiated SSC is more effective than late initiated SSC in reducing the stress level of newborns after cesarean deliveries.
H4: Early initiated SSC is more effective than late initiated SSC on the sucking success of newborns after cesarean deliveries.
H5: Early initiation of SSC is more effective than late initiation of SSC in increasing the satisfaction level of mothers after cesarean births.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SSC Group 1 (Operation room) | Active comparator | Other: SSC Group 1 (Operation room)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. |
| SSC Group 2 (Post-operation room) | Active comparator | Other: SSC Group 2 (Post-operation room)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Caesarean births performed with general anesthesia
- Normal births
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSC Group 1 (Operation room)Also: SSC1Salivary 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. | Other | SSC Group 1 (Operation room) |
| SSC Group 2 (Post-operation room)Also: SSC2SC 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. | Other | SSC Group 2 (Post-operation room) |
Primary outcome
Stress levels and sucking success of newborns
Time frame: From birth to the first 24 hours of life
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.
Pain and salivary cortisol (stress) levels of mothers
Time frame: From before transfer to the operation room until 1 hour after transfer to the ward room after birth.
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.
1 secondary outcome
Satisfaction levels o mothers regarding SSC application after cesarean delivery with spinal anesthesia
Time frame: From the first SSC application until 24 hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data may be shared by the corresponding author if requested by the journal editorship in which the study was published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSC Group 1 (Operation room) and SSC Group 2 (Post-operation room) in people with Skin-to-skin Contact, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress levels and sucking success of newborns (time frame: From birth to the first 24 hours of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.