Clinical trial NCT06502860: Skin-to-Skin Contact With a Sling in Primipar Mothers Who Delivered by Cesarean Section
Official title: Skin-to-Skin Contact With a Sling in Primipar Mothers Who Delivered by Cesarean Section
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Feeding
Caesarean Section;Stillbirth
Keywords: Skin-to-skin contact
Caesarean section
Breastfeeding success
Newborn physiological weight loss
Sling
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 68
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Experimental Design
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Introductory Information Form
timeFrame: Baseline (to both groups before the intervention)
measure: Skin-to-Skin Contact Tracking Form
timeFrame: To be completed during patient follow-up (postpartum days 0, 1, and 2)
measure: Breastfeeding Assessment Scale (LATCH)
timeFrame: To be completed during patient follow-up, once a day (postpartum days 0, 1, and 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Ataşehir
country: Turkey
facility: Merve Coşkun
state: İstanbul
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.