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Completed

NCT Number: NCT01862432

Immediate Skin-to-skin Contact After C-section

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate skin-to-skin

Other

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.

Primary outcomes

  1. Breastfeeding at six months

    Time frame: six months

Secondary outcomes

  1. Pain reactivity

    Time frame: one hour

    The newborn reactivity to pain is analyzed one hour after birth, at the injection of vitamin K, according to the Neonatal Infant Pain Scale.

  2. mother's satisfaction

    Time frame: 48 hours

    Mother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Acronym: CALIN

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 24, 2013
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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