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

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

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).

Study Overview

• Status: Completed
• Conditions: Elective Cesarean Section; Term Birth (Pregnancy)
• Intervention / Treatment: Other: Immediate skin-to-skin

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Breastfeeding at six months	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reactivity	The newborn reactivity to pain is analyzed one hour after birth, at the injection of vitamin K, according to the Neonatal Infant Pain Scale.	one hour
mother's satisfaction	Mother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section.	48 hours

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Jean-Charles Pasquier, MD, PhD, Universite de Sherbrooke

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): May 24, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10-097