Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 11:50 AM
Study NCT ID:
NCT01862432
Status:
COMPLETED
Last Update Posted:
2013-05-24
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Skin-to-skin Contact After C-section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding at six months', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'Pain reactivity', 'timeFrame': 'one hour', 'description': 'The newborn reactivity to pain is analyzed one hour after birth, at the injection of vitamin K, according to the Neonatal Infant Pain Scale.'}, {'measure': "mother's satisfaction", 'timeFrame': '48 hours', 'description': "Mother's satisfaction is evaluated by a questionnaire, within 48 hours after C-section."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elective Cesarean Section', 'Term Birth (Pregnancy)']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "Women are recruited before elective c-section.\n\nRandomizatiion is performed just before the operation.\n\nControl group:\n\nThe 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.\n\nIntervention group:\n\nThe 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.\n\nSampling (in both groups):\n\n* 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).\n* 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)\n* A cord blood sample is obtained for prolactin, ACTH and cortisol analysis.\n\nVideo recording:\n\nThe 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.\n\nSatisfaction:\n\nThe mother's satisfaction is evaluated with a questionnaire 24 to 48 hours after birth.\n\nBreastfeeding:\n\nThe breastfeeding is evaluated by a research nurse 1) at the hospital and 2) by phone interviews, up to 6 months after birth."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective C-section\n* term pregnancy\n* signature of an information and consent form\n\nExclusion Criteria:\n\n* multiple pregnancy\n* labor\n* fetal distress\n* abnormal anticipated birth weight\n* congenital malformation\n* diabetes\n* fever\n* rapid management of the new born required'}, 'identificationModule': {'nctId': 'NCT01862432', 'acronym': 'CALIN', 'briefTitle': 'Immediate Skin-to-skin Contact After C-section', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Immediate Skin-to-skin Contact After Caesarean Delivery to Improve Neonatal', 'orgStudyIdInfo': {'id': '10-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate skin-to-skin', 'interventionNames': ['Other: Immediate skin-to-skin']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'Immediate skin-to-skin', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['immediate skin-to-skin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Jean-Charles Pasquier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jean-Charles Pasquier, MD, PhD', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}