- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06502860
Skin-to-Skin Contact With a Sling in Primipar Mothers Who Delivered by Cesarean Section
The first hours after birth are critical for the physiological and psychological adaptation process of the newborn from intrauterine to extrauterine life. The World Health Organization (WHO) recommends skin-to-skin contact as a routine part of care to stabilize the newborn's vital signs and strengthen the mother-infant bond. However, the rate of skin-to-skin contact in women who give birth by cesarean section is lower compared to vaginal deliveries. Considering the global increase in cesarean birth rates, it is necessary to develop appropriate and practical care methods for mothers and newborns who deliver by cesarean section.
The literature has examined the effects of the duration of skin-to-skin contact on breastfeeding initiation, neonatal hypothermia, and cardiopulmonary stability. However, studies aimed at increasing the duration of skin-to-skin contact are limited. This study compares the effects of standard skin-to-skin contact and skin-to-skin contact using a sling on the duration of skin-to-skin contact, postpartum breastfeeding success, and physiological weight loss of the newborn in primiparous mothers who delivered by cesarean section.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Ataşehir, Istanbul, Turkey (Türkiye)
- Merve Coşkun
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy mothers who gave birth by cesarean section
- Primiparous mothers
- Healthy newborns
Exclusion Criteria:
- Mothers who gave birth vaginally
- Newborns using formula milk
- Mothers with breastfeeding difficulties
- Preterm newborns
- Multiple births
- Mothers and newborns with unstable health conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
The intervention group will receive skin-to-skin contact facilitated by the use of a sling.
Immediately after the cesarean section and stabilization, the newborn will be placed against the mother's bare chest using a specially designed sling.
This sling will secure the baby in a safe and comfortable position, allowing for continuous close contact.
The duration of skin-to-skin contact will be encouraged to last as long as the mother and baby are comfortable, without any set time limits.
|
In the intervention group, skin-to-skin contact will be facilitated using a specially designed sling.
This approach aims to enhance the quality and duration of skin-to-skin contact between the mother and the newborn.
|
|
No Intervention: Control Group
The control group will receive standard skin-to-skin contact without the use of a sling.
Immediately after the cesarean section and stabilization, the newborn will be placed directly on the mother's bare chest.
This traditional method will involve holding the baby manually to maintain skin-to-skin contact.
The duration of skin-to-skin contact will be encouraged to last as long as the mother and baby are comfortable, without any set time limits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: Baseline (to both groups before the intervention)
|
The introductory characteristics of the mother and newborn are documented in forms used by the institution during patient care and in records.
These forms are created by the researchers to systematize the information used in this study.
|
Baseline (to both groups before the intervention)
|
|
Skin-to-Skin Contact Tracking Form
Time Frame: To be completed during patient follow-up (postpartum days 0, 1, and 2)
|
This form is created by the researchers to determine the duration of skin-to-skin contact for each participant.
|
To be completed during patient follow-up (postpartum days 0, 1, and 2)
|
|
Breastfeeding Assessment Scale (LATCH)
Time Frame: To be completed during patient follow-up, once a day (postpartum days 0, 1, and 2)
|
The scale, developed by Jensen and Wallace in 1993, aims to objectively assess breastfeeding, identify breastfeeding problems, plan education, establish a common language among healthcare professionals, and be used in research (Jensen et al., 1994).
The scale was adapted into Turkish by Yenal and Okumuş in 2003 and consists of five assessment steps.
It is modeled after the APGAR scoring system and is quick and easy to use.
The acronym LATCH stands for the English terms of these assessment steps: "L = Latch on breast," "A = Audible swallowing," "T = Type of nipple," "C = Comfort breast/nipple," "H = Hold."
Each item is scored between 0-2 points.
The total possible score from the measurement tool is 10.
There is no cut-off point for the tool.
As the LATCH score increases, the success of breastfeeding is understood to be higher.
The scale has a Cronbach alpha value of .95
(Yenal and Okumuş, 2003).
|
To be completed during patient follow-up, once a day (postpartum days 0, 1, and 2)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Takahashi Y, Tamakoshi K, Matsushima M, Kawabe T. Comparison of salivary cortisol, heart rate, and oxygen saturation between early skin-to-skin contact with different initiation and duration times in healthy, full-term infants. Early Hum Dev. 2011 Mar;87(3):151-7. doi: 10.1016/j.earlhumdev.2010.11.012. Epub 2011 Jan 8.
- Wigglesworth H, Huddy V, Knowles R, Millings A. Evaluating the impact of sling provision and training upon maternal mental health, wellbeing and parenting: A randomised feasibility trial. PLoS One. 2023 Nov 10;18(11):e0293501. doi: 10.1371/journal.pone.0293501. eCollection 2023.
- Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.
- Gouchon S, Gregori D, Picotto A, Patrucco G, Nangeroni M, Di Giulio P. Skin-to-skin contact after cesarean delivery: an experimental study. Nurs Res. 2010 Mar-Apr;59(2):78-84. doi: 10.1097/NNR.0b013e3181d1a8bc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-5/171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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