NCT01862432

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

May 15, 2013

Last Update Submit

May 21, 2013

Conditions

Elective Cesarean SectionTerm Birth (Pregnancy)

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding at six months

    six months

Secondary Outcomes (2)

  • Pain reactivity

    one hour

  • mother's satisfaction

    48 hours

Study Arms (2)

immediate skin-to-skin

EXPERIMENTAL
Other: Immediate skin-to-skin

control

NO INTERVENTION

Interventions

Immediate skin-to-skinOTHER

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.

immediate skin-to-skin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective C-section
  • term pregnancy
  • signature of an information and consent form

You may not qualify if:

  • multiple pregnancy
  • labor
  • fetal distress
  • abnormal anticipated birth weight
  • congenital malformation
  • diabetes
  • fever
  • rapid management of the new born required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Officials

  • Jean-Charles Pasquier, MD, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 24, 2013

Study Start

June 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

CA(1)