Immediate Skin-to-skin Contact After C-section (CALIN)

Université de Sherbrooke

Status: Completed

Conditions: Term Birth (Pregnancy); Elective Cesarean Section

Treatments: Other: Immediate skin-to-skin

Study type: Interventional

Funder types: Other

Identifiers

NCT01862432

10-097

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

immediate skin-to-skin

Experimental group

Treatment:

Other: Immediate skin-to-skin

control

No Intervention group