Clinical trial NCT01862432: Immediate Skin-to-skin Contact After C-section
Official title: Immediate Skin-to-skin Contact After Caesarean Delivery to Improve Neonatal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Cesarean Section
Term Birth (Pregnancy)
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Breastfeeding at six months
timeFrame: six months
Secondary outcomes:
measure: Pain reactivity
timeFrame: one hour
measure: mother's satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Charles Pasquier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: