Immediate Skin-to-skin Contact After C-section

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Elective Cesarean Section, Term Birth (Pregnancy)

Intervention / Treatment
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* Other: Immediate skin-to-skin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate skin-to-skin<br> | Other: Immediate skin-to-skin<br>* 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.<br>|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |