- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07656207
The Effect of Skin-to-skin Contact at Birth
The Effect of Skin-to-skin Contact at Birth on Birth Outcomes and Parenting Behavior
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Skin-to-skin contact (STSC) involves placing the baby on the mother's chest for at least one hour during or immediately after birth. After birth, healthy, full-term babies who receive STSC will orient themselves toward their mother's breast and nipple and begin suckling within approximately one hour. This practice has many benefits for both mother and baby. Looking at the benefits for the mother, these include earlier placental separation, reduced postpartum bleeding, increased breastfeeding self-efficacy, and decreased stress levels in the mother. Furthermore, the rise in oxytocin levels in the mother within the first hour after birth promotes the development and strengthening of the bond between mother and baby. The benefits for the baby include a reduction in adverse outcomes associated with birth stress, effective thermoregulation, less and shorter crying, a decrease in the likelihood of apnea, less physiological weight loss, and less stress response to painful procedures. At the same time, it has been shown that SC reduces the rate of formula supplementation in hospitals, increases the initiation of breastfeeding and the level of exclusive breastfeeding, and leads to successful first breastfeeding and optimal suckling. The timing and duration of skin-to-skin contact (STSC) vary. In this study, skin-to-skin contact will be performed immediately after birth.
STSC 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, aspiration can be performed while the baby is on the mother's abdomen or chest, and the baby is thoroughly dried. To prevent heat loss, the baby's back is covered with a pre-warmed blanket and a hat is placed on the head. All other interventions on the newborn can be delayed until at least the end of the first hour after birth or the first successful breastfeeding.
Skin-to-skin contact between the mother and baby is noted as one of the most effective practices to support placental separation during the third stage of labor. This practice not only contributes to the baby's physiological adaptation but also strengthens the mother-baby bond. Skin-to-skin contact is reported to increase oxytocin release, helping the placenta separate more easily and quickly.
The first two hours after birth, when newborns are most sensitive to sensory cues such as their mother's warmth, touch, and smell, are considered the most appropriate time for initiating breastfeeding and establishing bonding. The aim of skin-to-skin contact is to initiate the first breastfeeding after birth as early as possible. This helps to initiate breastfeeding early, strengthening the emotional bond between mother and baby and contributing to a longer breastfeeding period. It is recommended that breastfeeding begin within the first half hour after birth through skin-to-skin contact.
Childbirth is a unique process that is perceived and experienced differently by each woman and is considered an important step in the transition to parenthood. Ensuring that this process occurs in line with the mother's expectations helps to make the postpartum period more peaceful and healthy. The baby, who is in constant physical contact with the mother during the intrauterine period, maintains continuity of communication by establishing contact with the mother after birth. Maintaining this contact in the postpartum period is an important requirement that supports the physical and psychological well-being of both the mother and the baby.
Skin-to-skin contact (STSC), as the first physical bond established between the mother and newborn immediately after birth, is a fundamental practice that brings many positive physiological and psychosocial effects. In this context, examining the effects of skin-to-skin contact during birth on both birth outcomes (such as placental separation time, postpartum pain, timing of first breastfeeding, and motivation) and parenting behaviors is of great importance for developing evidence-based approaches in birth care.
The findings obtained will contribute to midwifery practices in childbirth and postnatal care, thereby providing a basis for strengthening policies aimed at supporting maternal and newborn health.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: tuğçe sönmez
- Numer telefonu: +905541804484
- E-mail: tugcesonmez@tarsus.edu.tr
Lokalizacje studiów
-
-
Mersin
-
Toroslar, Mersin, Turcja (Türkiye), 33000
- Tarsus University
-
Kontakt:
- tuğçe sönmez
- Numer telefonu: 05541804484
- E-mail: tugcesonmez@tarsus.edu.tr
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Vaginal delivery
- Primiparous pregnancy
- Delivery at 37 weeks or later
- Single, live fetus
- Not a high-risk pregnancy
- Not an individual with special needs
- Able to communicate
Exclusion Criteria:
- Women who Have a multiple pregnancy,
- Develop complications requiring emergency intervention in the mother or baby after delivery,
- Have their baby admitted to the neonatal intensive care unit after delivery,
- Have a cesarean section,
- Withdraw from the study will be excluded from the research.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Control group
Mothers and newborns in the control group will not receive any procedures; they will undergo the hospital's routine procedures.
|
|
|
Eksperymentalny: Immediate Skin-to-Skin Contact After Birth (intervention group)
Immediate skin-to-skin contact after birth: If the newborn requires no intervention, they will be immediately placed on the mother's chest (before cord clamping) and skin-to-skin contact will begin.
Skin-to-skin contact will be maintained for approximately 60 minutes until the first breastfeeding occurs.
All routine procedures performed in the delivery room for the newborn (except for weight measurement) will be performed while the newborn is on the mother's chest.
|
Immediate skin-to-skin contact after birth: If the newborn requires no intervention, they will be immediately placed on the mother's chest (before cord clamping) and skin-to-skin contact will begin.
Skin-to-skin contact will be maintained for approximately 60 minutes until the first breastfeeding occurs.
All routine procedures performed in the delivery room for the newborn (except for weight measurement) will be performed while the newborn is on the mother's chest.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Personal Information Form
Ramy czasowe: baseline
|
The form prepared by the researchers consists of 14 questions about the mothers' socio-demographic characteristics, obstetric characteristics, and newborns.
|
baseline
|
|
Breastfeeding Motivation Scale
Ramy czasowe: Periprocedural
|
The Breastfeeding Motivation Scale, based on Self-Determination Theory, was developed by Peleg et al. (2015).
It was adapted into Turkish by Şahin et al. in 2017, and a validity and reliability study was conducted.
Exploratory factor analysis revealed that the Turkish version consists of 23 items and five sub-factors for primiparous mothers, and 24 items and six sub-factors for multiparous mothers.
According to the calculated Cronbach's alpha value, the Breastfeeding Motivation Scale is a highly reliable scale for both primiparous (Cronbach's alpha: 0.887) and multiparous (Cronbach's alpha: 0.914) mothers.
The scale consists of 24 items and 5 sub-dimensions.
The items are rated on a 4-point Likert scale, with each item receiving a score between 1 and 4. The total score of the scale is calculated by averaging the scores of the sub-dimensions.
As the score obtained from a subscale increases, it is interpreted as an increase in the motivation represented by that subscale.
|
Periprocedural
|
|
VAS
Ramy czasowe: Periprocedural
|
The VAS (Visual Assessment Scale) is one of the most commonly used measurement tools for determining pain intensity.
The VAS consists of a line drawn on a horizontal or vertical axis, 10 cm or 100 mm long.
At one end of this line is the word "no pain," and at the other end is the word "unbearable pain."
The distance from the lowest VAS value to the point marked by the pregnant woman is measured in cm or mm to determine the numerical value of the pain intensity.
The evaluation is based on these markings.
The VAS is considered a successful measurement tool for evaluating the effectiveness of pain relief methods (Demir, 2012; Carvalho & Cohen, 2013).
|
Periprocedural
|
|
Postnatal Parenting Behavior Scale
Ramy czasowe: Periprocedural
|
The scale was developed by Britton et al. in 2001 to evaluate the behaviors exhibited by parents during their first interactions after birth (Britton et al., 2001). The Turkish adaptation, validity, and reliability study of the scale was conducted by Çalışır et al. (2009) (Çalışır et al., 2009). This scale aims to evaluate the parenting behaviors of the mother or father during their first encounter with their baby immediately after birth through observation. In the six-item scale, the observer records whether the parent exhibits each behavior; behaviors performed are indicated with a "+" sign, and those not performed with a "-" sign. A score of "1" is given for each observed behavior, and a score of "0" for each unobserved behavior. Thus, the total score that can be obtained from the scale ranges from 0 to 6. A high score indicates that the parent exhibits more positive and supportive parenting behaviors towards their baby. |
Periprocedural
|
|
Skin-to-Skin Contact, Placental Separation, and Breastfeeding Process Tracking Form
Ramy czasowe: Periprocedural
|
This form was created by researchers.
It is used to record information about when mothers started skin-to-skin contact, the duration of skin-to-skin contact, the time they started breastfeeding, the duration of breastfeeding, and the time it took for placental separation.
|
Periprocedural
|
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Serap Ejder Apay, Prof., Ataturk University
- Krzesło do nauki: Mehtap Begüm Orak, Master's student, Ataturk University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Birthskincontact
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Kontakt skóra do skóry
-
Northwestern UniversityUniversity of Wisconsin, StoutZakończonyPostrzeganie klinik Skin of Color u AfroamerykanówStany Zjednoczone