BreastfeedingNCT06514352
The Effect of Skin-to-Skin Contact Based on Clinical Guidelines
A study testing Skin contact immediately after birth, Very Early Skin contact and Early Skin contact in people with Breastfeeding and Newborn, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. 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
- Breastfeeding, Newborn
- What is being tested?
- Skin contact immediately after birth, Very Early Skin contact and Early Skin contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 8 Apr 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Giving birth vaginally
- Primiparous pregnant
- Giving birth at 37 weeks or more
- Single and alive fetus
- Not being pregnant at risk
- Not being an individual with special needs
- Ability to communicate with the pregnant woman
- Stay in the neonatal intensive care unit for less than 24 hours
Who cannot join
- Having multiple pregnancies,
- Women who gave up participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Skin-to-Skin Contact Based on Clinical Guidelines on Newborn Stress and Breastfeeding Success
Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. Health professionals use evidence-based practices revealed by scientific studies in their care approaches. Care and follow-up immediately after birth are very important. When the investigators look at the neonatal mortality rate in our country in 2019, it is shown as 5.3 per thousand and 5 per thousand in 2020. Therefore, neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates.
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period, can initiate breastfeeding in the early period, and ensure optimal continuation of breastfeeding.
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth. These monitoring must be done according to the criteria. Genç et al. in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period. (2023) skin-to-skin contact will be made between the mother and the newborn in accordance with the "Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide".
Read the detailed description
Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. Health professionals use evidence-based practices revealed by scientific studies in their care approaches. Care and follow-up immediately after birth are very important. When the investigators look at the neonatal mortality rate in our country in 2019, it is shown as 5.3 per thousand and 5 per thousand in 2020. Therefore, neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates.
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period, can initiate breastfeeding in the early period, and ensure optimal continuation of breastfeeding.
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth. These monitoring must be done according to the criteria. Genç et al. in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period. (2023) skin-to-skin contact will be made between the mother and the newborn in accordance with the "Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide".
Skin-to-skin contact (SC) is the placement of the baby on the mother's chest for at least one hour at birth or immediately after birth. A healthy, full-term baby who receives SC after birth directs himself to his mother's breast and nipple and starts sucking for about an hour. This application has many benefits for mother and baby. If the investigators look at the benefits for the mother; earlier separation of the placenta, reduced postpartum bleeding, increased breastfeeding self-efficacy, and reduced maternal stress levels. In addition, the increase in the mother's oxytocin level in the first hour after birth ensures the development and strengthening of bonding between mother and baby. The benefits for the baby are; These include reducing the negative consequences that may develop due to birth stress, effective thermoregulation, crying less and for a shorter period of time, reducing the likelihood of apnea, less physiological weight loss, and less stress response to painful procedures. At the same time, while SC reduces the rate of formula supplementation in the hospital, it has been shown to increase the initiation of breastfeeding and the level of exclusive breastfeeding, leading to a successful first breastfeeding and optimal breastfeeding.
SC application time and durations vary. SC at birth or immediately after birth: The newborn is placed face to face on the mother's abdomen or chest within the first minute after birth. If medically necessary, suctioning can be done while on the mother's abdomen or chest and the baby is dried thoroughly. To prevent heat loss, the baby's back is covered with a pre-warmed blanket and a hat is placed on his head. All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding.
Very early SC: Within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, the newborn is placed face down on the mother's bare chest, naked with or without a hat. The newborn's back can be covered with a blanket.
Early SC: It can begin any time between the first hour and 24 hours after birth. The baby is naked (with or without a diaper) and placed face down on the mother's bare chest between the breasts. The mother can wear a blouse or shirt that opens at the front, or a hospital gown that can be tied at the back. The baby is placed inside the apron so that only the head is exposed. What the mother wears, how the baby is kept warm, and what is placed on the baby's back may vary. The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm.
A thesis study was planned to examine the relationship between skin-to-skin contact, which will be applied within the framework of these application timings, and neonatal stress and suckling success.
The thesis study was planned as a randomized controlled experimental study. The thesis is planned to be carried out at Tarsus State Hospital Maternity Room between August 2024 and January 2025.
The population of the study will be women who applied to Tarsus State Hospital Maternity Room for birth between the dates of the study. The sample consists of 48 (group 1 - sc immediately after birth), 48 (group 2 - very early sc), 48 (group 3 - early sc), 48 control group, who met the selection criteria, agreed to participate in the thesis study and were determined by power analysis. It will consist of a total of 192 women.
As data collection tools, socio-demographic characteristics introduction and questionnaire for skin contact and breastfeeding process, Skin Contact and Breastfeeding Process Follow-up Form, LATCH Breastfeeding Diagnosis Measurement Tool and Newborn Stress Scale will be used.
Socio-Demographic Characteristics Introduction and Questionnaire for Skin Contact and Breastfeeding Process: The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses, the obstetric characteristics of the mothers and the newborn.
Skin Contact and Breastfeeding Process Follow-up Form: The form was created by researchers. This is the form in which information about the time when mothers start to apply skin-to-skin contact, the duration of skin-to-skin contact, the time to start breastfeeding, the duration of breastfeeding and the time for the baby to settle on the breast will be recorded.
LATCH Breastfeeding Diagnostic Measurement Tool: Breastfeeding status of mothers in the intervention and control groups in the postpartum period will be evaluated using the LATCH scale. LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic; It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding. Scoring is between 0-2 and the maximum score that can be obtained is 10. In the measurement tool that does not have a cut-off point, a high score indicates that breastfeeding is successful. The reliability study was conducted by Adams and Hewell in 1997. The Turkish reliability study of the scale was conducted by Yenal and Okumuş (2003) and the Chronbach alpha value was found to be 0.95.
Newborn Stress Scale: The Newborn Stress Scale, developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature babies, is suitable for use in term babies. Scale items were collected in 8 subgroups in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. In scoring, each subgroup is evaluated between 0-2 points.
A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases. Cronbach's alpha coefficient has been reported to be between 0.65-0.81.
Application Steps Group 1- SC Immediately After Birth: In the immediate skin-to-skin contact group after birth, if the newborn does not need any intervention, it will be placed on the mother's chest immediately (without cord clamping) and skin-to-skin contact will begin. An average of 60 minutes of skin contact will be made until the first breastfeeding occurs. All routine practices for the newborn in the delivery room (except weight measurement) will be performed on the mother's chest.
Group 2- Very Early SC: In the very early SC group, skin-to-skin contact will begin within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs.
Group 3- Early SC: For the newborn who needs intervention after birth and for whom skin-to-skin contact cannot be started in the delivery room, skin-to-skin contact will begin within the first 24 hours after birth, after the newborn becomes stable.
Control group: No treatment will be performed on the mothers and newborns in the control group, and the hospital's routine practices will be carried out.
Newborn stress and LATCH score will be evaluated at the 12th and 24th hours after birth in all groups.
- Conditions
- Breastfeeding, Newborn
- Being tested
- Skin contact immediately after birth, Very Early Skin contact, Early Skin contact
- Keywords
- skin to contact, breastfeeding, newborn
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin contact immediately after birthOther
In the immediate skin-to-skin contact group after birth, if the newborn does not need any intervention, he will be placed on the mother's chest immediately (without cord clamping) and skin-to-skin contact will begin. An average of 60 minutes of skin contact will be made until the first breastfeeding occurs. All routine practices for the newborn in the delivery room (except weight measurement) will be performed on the mother's chest. (n=48)
Very Early Skin contactOther
In the very early skin-to-skin contact group, skin-to-skin contact will begin within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs.(n=48)
Early Skin contactOther
For newborns who need intervention after birth and whose skin-to-skin contact cannot be started in the delivery room, skin-to-skin contact will begin within the first 24 hours after birth, after the newborn becomes stable.(n=48)
| Study group | Role | What they receive |
|---|---|---|
| skin-to-skin contact group immediately after birth | Experimental | The newborn is placed face to face on the mother's abdomen or chest in the first minute after birth. If medically necessary, suctioning can be done while on the mother's abdomen or chest and the baby is dried thoroughly. To prevent heat loss, the baby's back is covered with a pre-warmed blanket and a hat is placed on his head. All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding. Receives: Other: Skin contact immediately after birth |
| very early skin contact group | Experimental | In the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, the newborn is placed face down on the mother's bare chest, naked with or without a hat. The newborn's back can be covered with a blanket. Receives: Other: Very Early Skin contact |
| early skin contact group | Experimental | It can start any time between the first hour and 24 hours after birth. The baby is naked (with or without a diaper) and placed face down on the mother's bare chest between the breasts. The mother can wear a blouse or shirt that opens at the front, or a hospital gown that can be tied at the back. The baby is placed inside the apron so that only the head is exposed. What the mother wears, how the baby is kept warm, and what is placed on the baby's back may vary. The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm. Receives: Other: Early Skin contact |
| control group | No intervention | No treatment will be performed on the mothers and newborns in the control group, and the hospital's routine practices (birthing support, newborn and maternal care) will be carried out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Question Form for Socio-Demographic Characteristics Introduction and Skin Contact and Breastfeeding Process
The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses, the obstetric characteristics of the mothers and the newborn.
Measured: immediately before intervention
Skin Contact and Breastfeeding Process Follow-up Form
The form was created by researchers. This is the form in which information about the time when mothers start to apply skin-to-skin contact, the duration of skin-to-skin contact, the time to start breastfeeding, the duration of breastfeeding and the time for the baby to settle on the breast will be recorded.
Measured: immediately after the intervention
LATCH Breastfeeding Diagnostic Measurement Tool
During the postpartum period, the breastfeeding status of mothers in the intervention and control groups will be evaluated using the LATCH scale. LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic; It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding. Scoring is between 0-2 and the maximum score that can be obtained is 10. In the measurement tool that does not have a cut-off point, a high score indicates that breastfeeding is successful. The reliability study was conducted by Adams and Hewell in 1997. The Turkish reliability study of the scale was conducted by Yenal and Okumuş (2003) and the Chronbach alpha value was found to be 0.95.
Measured: immediately after the intervention, 12 hours after birth, 24 hour after birth
Newborn Stress Scale
Newborn Stress Scale: The Newborn Stress Scale, developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature babies, is suitable for use in term babies. The scale items were collected in 8 subgroups in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. In scoring, each subgroup is evaluated between 0-2 points.
A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases. Cronbach's alpha coefficient has been reported to be between 0.65-0.81
Measured: immediately after the intervention, 12 hours after birth, 24 hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start30 Dec 2024
- Primary completion15 Feb 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Sonmez, Gaziantep Islam Science and Technology University
- Investigators
- Emine Serap Çağan, Dr., Study chair, Ağrı Ibrahim Çeçen UniversityEda Akbaş, Midwife, Principal investigator, Tarsus public hospitaltuğçe sönmez, Dr., Study chair, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514352
- Sponsor's protocol ID
- 3304skincontact
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Skin-to-Skin Contact Based on Clinical Guidelines on Newborn Stress and Breastfeeding Success
- ClinicalTrials.gov ID
- NCT06514352
- Acronym / sponsor ID
- 3304skincontact
- Conditions
- Breastfeeding, Newborn
- Keywords
- skin to contact, breastfeeding, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 23 Jul 2024 (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.
Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. Health professionals use evidence-based practices revealed by scientific studies in their care approaches. Care and follow-up immediately after birth are very important. When the investigators look at the neonatal mortality rate in our country in 2019, it is shown as 5.3 per thousand and 5 per thousand in 2020. Therefore, neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates.
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period, can initiate breastfeeding in the early period, and ensure optimal continuation of breastfeeding.
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth. These monitoring must be done according to the criteria. Genç et al. in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period. (2023) skin-to-skin contact will be made between the mother and the newborn in accordance with the "Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide".
Detailed description
Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. Health professionals use evidence-based practices revealed by scientific studies in their care approaches. Care and follow-up immediately after birth are very important. When the investigators look at the neonatal mortality rate in our country in 2019, it is shown as 5.3 per thousand and 5 per thousand in 2020. Therefore, neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates.
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period, can initiate breastfeeding in the early period, and ensure optimal continuation of breastfeeding.
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth. These monitoring must be done according to the criteria. Genç et al. in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period. (2023) skin-to-skin contact will be made between the mother and the newborn in accordance with the "Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide".
Skin-to-skin contact (SC) is the placement of the baby on the mother's chest for at least one hour at birth or immediately after birth. A healthy, full-term baby who receives SC after birth directs himself to his mother's breast and nipple and starts sucking for about an hour. This application has many benefits for mother and baby. If the investigators look at the benefits for the mother; earlier separation of the placenta, reduced postpartum bleeding, increased breastfeeding self-efficacy, and reduced maternal stress levels. In addition, the increase in the mother's oxytocin level in the first hour after birth ensures the development and strengthening of bonding between mother and baby. The benefits for the baby are; These include reducing the negative consequences that may develop due to birth stress, effective thermoregulation, crying less and for a shorter period of time, reducing the likelihood of apnea, less physiological weight loss, and less stress response to painful procedures. At the same time, while SC reduces the rate of formula supplementation in the hospital, it has been shown to increase the initiation of breastfeeding and the level of exclusive breastfeeding, leading to a successful first breastfeeding and optimal breastfeeding.
SC application time and durations vary. SC at birth or immediately after birth: The newborn is placed face to face on the mother's abdomen or chest within the first minute after birth. If medically necessary, suctioning can be done while on the mother's abdomen or chest and the baby is dried thoroughly. To prevent heat loss, the baby's back is covered with a pre-warmed blanket and a hat is placed on his head. All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding.
Very early SC: Within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, the newborn is placed face down on the mother's bare chest, naked with or without a hat. The newborn's back can be covered with a blanket.
Early SC: It can begin any time between the first hour and 24 hours after birth. The baby is naked (with or without a diaper) and placed face down on the mother's bare chest between the breasts. The mother can wear a blouse or shirt that opens at the front, or a hospital gown that can be tied at the back. The baby is placed inside the apron so that only the head is exposed. What the mother wears, how the baby is kept warm, and what is placed on the baby's back may vary. The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm.
A thesis study was planned to examine the relationship between skin-to-skin contact, which will be applied within the framework of these application timings, and neonatal stress and suckling success.
The thesis study was planned as a randomized controlled experimental study. The thesis is planned to be carried out at Tarsus State Hospital Maternity Room between August 2024 and January 2025.
The population of the study will be women who applied to Tarsus State Hospital Maternity Room for birth between the dates of the study. The sample consists of 48 (group 1 - sc immediately after birth), 48 (group 2 - very early sc), 48 (group 3 - early sc), 48 control group, who met the selection criteria, agreed to participate in the thesis study and were determined by power analysis. It will consist of a total of 192 women.
As data collection tools, socio-demographic characteristics introduction and questionnaire for skin contact and breastfeeding process, Skin Contact and Breastfeeding Process Follow-up Form, LATCH Breastfeeding Diagnosis Measurement Tool and Newborn Stress Scale will be used.
Socio-Demographic Characteristics Introduction and Questionnaire for Skin Contact and Breastfeeding Process: The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses, the obstetric characteristics of the mothers and the newborn.
Skin Contact and Breastfeeding Process Follow-up Form: The form was created by researchers. This is the form in which information about the time when mothers start to apply skin-to-skin contact, the duration of skin-to-skin contact, the time to start breastfeeding, the duration of breastfeeding and the time for the baby to settle on the breast will be recorded.
LATCH Breastfeeding Diagnostic Measurement Tool: Breastfeeding status of mothers in the intervention and control groups in the postpartum period will be evaluated using the LATCH scale. LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic; It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding. Scoring is between 0-2 and the maximum score that can be obtained is 10. In the measurement tool that does not have a cut-off point, a high score indicates that breastfeeding is successful. The reliability study was conducted by Adams and Hewell in 1997. The Turkish reliability study of the scale was conducted by Yenal and Okumuş (2003) and the Chronbach alpha value was found to be 0.95.
Newborn Stress Scale: The Newborn Stress Scale, developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature babies, is suitable for use in term babies. Scale items were collected in 8 subgroups in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. In scoring, each subgroup is evaluated between 0-2 points.
A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases. Cronbach's alpha coefficient has been reported to be between 0.65-0.81.
Application Steps Group 1- SC Immediately After Birth: In the immediate skin-to-skin contact group after birth, if the newborn does not need any intervention, it will be placed on the mother's chest immediately (without cord clamping) and skin-to-skin contact will begin. An average of 60 minutes of skin contact will be made until the first breastfeeding occurs. All routine practices for the newborn in the delivery room (except weight measurement) will be performed on the mother's chest.
Group 2- Very Early SC: In the very early SC group, skin-to-skin contact will begin within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs.
Group 3- Early SC: For the newborn who needs intervention after birth and for whom skin-to-skin contact cannot be started in the delivery room, skin-to-skin contact will begin within the first 24 hours after birth, after the newborn becomes stable.
Control group: No treatment will be performed on the mothers and newborns in the control group, and the hospital's routine practices will be carried out.
Newborn stress and LATCH score will be evaluated at the 12th and 24th hours after birth in all groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| skin-to-skin contact group immediately after birth | Experimental | Other: Skin contact immediately after birthThe newborn is placed face to face on the mother's abdomen or chest in the first minute after birth. If medically necessary, suctioning can be done while on the mother's abdomen or chest and the baby is dried thoroughly. To prevent heat loss, the baby's back is covered with a pre-warmed blanket and a hat is placed on his head. All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding. |
| very early skin contact group | Experimental | Other: Very Early Skin contactIn the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, the newborn is placed face down on the mother's bare chest, naked with or without a hat. The newborn's back can be covered with a blanket. |
| early skin contact group | Experimental | Other: Early Skin contactIt can start any time between the first hour and 24 hours after birth. The baby is naked (with or without a diaper) and placed face down on the mother's bare chest between the breasts. The mother can wear a blouse or shirt that opens at the front, or a hospital gown that can be tied at the back. The baby is placed inside the apron so that only the head is exposed. What the mother wears, how the baby is kept warm, and what is placed on the baby's back may vary. The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm. |
| control group | No intervention | –No treatment will be performed on the mothers and newborns in the control group, and the hospital's routine practices (birthing support, newborn and maternal care) will be carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Giving birth vaginally
- Primiparous pregnant
- Giving birth at 37 weeks or more
- Single and alive fetus
- Not being pregnant at risk
Key exclusion criteria (2 listed)
- Having multiple pregnancies,
- Women who gave up participating in the study
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 |
|---|---|---|
| Skin contact immediately after birthIn the immediate skin-to-skin contact group after birth, if the newborn does not need any intervention, he will be placed on the mother's chest immediately (without cord clamping) and skin-to-skin contact will begin. An average of 60 minutes of skin contact will be made until the first breastfeeding occurs. All routine practices for the newborn in the delivery room (except weight measurement) will be performed on the mother's chest. (n=48) | Other | skin-to-skin contact group immediately after birth |
| Very Early Skin contactIn the very early skin-to-skin contact group, skin-to-skin contact will begin within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs.(n=48) | Other | very early skin contact group |
| Early Skin contactFor newborns who need intervention after birth and whose skin-to-skin contact cannot be started in the delivery room, skin-to-skin contact will begin within the first 24 hours after birth, after the newborn becomes stable.(n=48) | Other | early skin contact group |
Primary outcome
Question Form for Socio-Demographic Characteristics Introduction and Skin Contact and Breastfeeding Process
Time frame: immediately before intervention
The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses, the obstetric characteristics of the mothers and the newborn.
Skin Contact and Breastfeeding Process Follow-up Form
Time frame: immediately after the intervention
The form was created by researchers. This is the form in which information about the time when mothers start to apply skin-to-skin contact, the duration of skin-to-skin contact, the time to start breastfeeding, the duration of breastfeeding and the time for the baby to settle on the breast will be recorded.
LATCH Breastfeeding Diagnostic Measurement Tool
Time frame: immediately after the intervention, 12 hours after birth, 24 hour after birth
During the postpartum period, the breastfeeding status of mothers in the intervention and control groups will be evaluated using the LATCH scale. LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic; It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding. Scoring is between 0-2 and the maximum score that can be obtained is 10. In the measurement tool that does not have a cut-off point, a high score indicates that breastfeeding is successful. The reliability study was conducted by Adams and Hewell in 1997. The Turkish reliability study of the scale was conducted by Yenal and Okumuş (2003) and the Chronbach alpha value was found to be 0.95.
Newborn Stress Scale
Time frame: immediately after the intervention, 12 hours after birth, 24 hour after birth
Newborn Stress Scale: The Newborn Stress Scale, developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature babies, is suitable for use in term babies. The scale items were collected in 8 subgroups in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases. Cronbach's alpha coefficient has been reported to be between 0.65-0.81
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 1 May 2026.
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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.
Emine Serap Çağan, Dr. study chair
Ağrı Ibrahim Çeçen University
Eda Akbaş, Midwife principal investigator
Tarsus public hospital
tuğçe sönmez, Dr. study chair
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin contact immediately after birth, Very Early Skin contact and Early Skin contact in people with Breastfeeding and Newborn, run by Gaziantep Islam Science and Technology 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 8 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 1 May 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?
Question Form for Socio-Demographic Characteristics Introduction and Skin Contact and Breastfeeding Process (time frame: immediately before intervention). The study lists 4 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 1 May 2026.