Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
NCT Number: NCT01862432
At birth, the passage from intrauterine to the aerial life can be considered as one of the most stressful and painful life events. Skin-to-skin contact (STSC) with mother is known to provide numerous virtues and World Health Organisation (WHO) recently supported the introduction of such care among healthy, term-born neonates. Here, the investigators hypothesized that immediate STSC could reduce neonatal, birth-evoked stress and pain. This randomized controlled trial (RCT) aimed to compare the pain and stress response of C-section born neonates that received either immediate STSC with mother (intervention) or classical support and monitoring (control).
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Notify Me18 year and older
Female
Interventional
Not applicable
Sherbrooke, Quebec, J1H 5N4, Canada
Women are recruited before elective c-section.
Randomizatiion is performed just before the operation.
Control group:
The operation is performed as usual, with observation of the newborn by medical staff. The newborn is then wrapped in a blanket and given to the father.
Intervention group:
The newborn is given to the mother in the first minute of life, placed on her chest to allow complete skin-to-skin contact. Observation of the baby is performed in this position. The skin-to-skin contact lasts as long as the operation is not completed or the mother is not able anymore to keep her baby on her chest.
Sampling (in both groups):
Video recording:
The newborn is video recorded at the vitamin K injection (from 1 minute before the injection to 5 minutes after) for analysis with the Neonatal Infant Pain Scale.
Satisfaction:
The mother's satisfaction is evaluated with a questionnaire 24 to 48 hours after birth.
Breastfeeding:
The breastfeeding is evaluated by a research nurse 1) at the hospital and 2) by phone interviews, up to 6 months after birth.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The newborn is place on his mother's chest, immediately (in the first minute of life), in order to allow complete skin-to-skin contact.
Time frame: six months
Time frame: one hour
The newborn reactivity to pain is analyzed one hour after birth, at the injection of vitamin K, according to the Neonatal Infant Pain Scale.
Time frame: 48 hours
Mother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section.
Université de Sherbrooke
Other
Immediate Skin-to-skin Contact After Caesarean Delivery to Improve Neonatal
Acronym: CALIN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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