CALIN: Immediate Skin-to-skin Contact After C-section
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: immediate skin-to-skin
|
Other: Immediate 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.
|
| No Intervention: control
|
Outcome Measures
Primary Outcome Measures
- Breastfeeding at six months [six months]
Secondary Outcome Measures
- Pain reactivity [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.
- mother's satisfaction [48 hours]
Mother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- Université de Sherbrooke
Investigators
- Principal Investigator: Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10-097