Immediate Skin-to-skin Contact After C-section

Elective Cesarean Section Clinical Trial

— CALIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862432
• Other study ID #: 10-097
• Status: Completed
• Phase: N/A
• First received: May 15, 2013
• Last updated: May 21, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Elective Cesarean Section
• Term Birth (Pregnancy)

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding at six months		six months	No
Secondary	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	No
Secondary	mother's satisfaction	Mother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section.	48 hours	No