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Immediate Skin-to-skin Contact After C-section

Immediate Skin-to-skin Contact After Caesarean Delivery to Improve Neonatal

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01862432
Acronym
CALIN
Enrollment
60
Registered
2013-05-24
Start date
2011-06-30
Completion date
2013-02-28
Last updated
2013-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Cesarean Section, Term Birth (Pregnancy)

Brief summary

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).

Detailed description

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): * salivary samples are obtained with salivettes from the mother 1)before the operation and 2) after the operation, in the recovery room (90 minutes after birth). * salivary samples are obtained with salivettes from the newborn 1) 20 minutes after birth and 2) 20 minutes after the vitamin K injection (performed at 60 minutes of life) * A cord blood sample is obtained for prolactin, ACTH and cortisol analysis. 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.

Interventions

OTHERImmediate skin-to-skin

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.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* elective C-section * term pregnancy * signature of an information and consent form

Exclusion criteria

* multiple pregnancy * labor * fetal distress * abnormal anticipated birth weight * congenital malformation * diabetes * fever * rapid management of the new born required

Design outcomes

Primary

MeasureTime frame
Breastfeeding at six monthssix months

Secondary

MeasureTime frameDescription
Pain reactivityone hourThe newborn reactivity to pain is analyzed one hour after birth, at the injection of vitamin K, according to the Neonatal Infant Pain Scale.
mother's satisfaction48 hoursMother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026