Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT01793558
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-11', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-02-14', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Shivering incidence of the mothers', 'timeFrame': '20 min after child birth', 'description': 'Shivering of the mothers will be graded by a four-point scale.'}, {'measure': 'Thermal comfort of the mothers', 'timeFrame': '20 min after child birth', 'description': 'Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.'}, {'measure': 'Mean arterial blood pressure of the mothers.', 'timeFrame': '20 min after child birth', 'description': 'Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.'}, {'measure': 'Core temperature of the mothers', 'timeFrame': '20 min after child birth', 'description': 'Core temperature will be measured by a sublingual temperature probe.'}, {'measure': 'Skin temperature of the mothers.', 'timeFrame': '20 min after child birth', 'description': 'Skin temperature of the mothers will be assessed at the chest.'}], 'primaryOutcomes': [{'measure': 'Body core temperature of the newborn', 'timeFrame': '20 min after birth', 'description': 'Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.'}], 'secondaryOutcomes': [{'measure': 'Skin temperature of the newborn', 'timeFrame': '20 min after child birth', 'description': 'Skin temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period) at chest, arm, thigh, and calf. Mean-skin temperature will be calculated from these measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thermoregulation Impairment', 'hypothermia', 'Postoperative shivering', 'cesarean section', 'newborn'], 'conditions': ['Thermoregulation Impairment', 'Hypothermia', 'Postoperative Shivering']}, 'descriptionModule': {'briefSummary': 'This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.\n\nTherefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. The investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.', 'detailedDescription': 'Little is known about the thermoregulatory effects on babies when bonding on the chest of the mother during caesarian section. The aim of our study is to evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest. The investigators want to investigate the effects of active cutaneous warming of the mothers and babies during a 20 min intraoperative bonding period. The investigators plan to enroll 40 parturients scheduled for elective caesarean section under spinal anaesthesia to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '20 Minutes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parturients undergoing planned, elective cesarean section under spinal anaesthesia\n* mothers classified as American Society of Anaesthesiologists (ASA) status I or II\n* written informed consent\n\nExclusion Criteria:\n\n* mothers younger than 18 years\n* mothers classified as American Society of Anaesthesiologists (ASA) status III or higher\n* caesarean section planned under general anaesthesia.\n* any expected problems with the newborn such as:\n\n * gestation date \\< 36 or \\> 42 week\n * placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)'}, 'identificationModule': {'nctId': 'NCT01793558', 'acronym': 'THER5', 'briefTitle': 'Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section', 'orgStudyIdInfo': {'id': 'THER-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control; passive insulation', 'description': 'The mothers will receive passive temperature insulation by a cotton blanket (standard procedure) after start of the spinal anaesthesia for cesarean section. The newborn will be bonded on the mothers chest under the cotton blanket (also passive insulation without active warming) for 20 min after birth (bonding period).'}, {'type': 'EXPERIMENTAL', 'label': 'Active Warming', 'description': 'The mothers will receive active warming by a forced-air warming blanket after start of the spinal anaesthesia for cesarean section. The newborn will be bonded on the mothers chest under the warming blanket for 20 min after birth (bonding period).', 'interventionNames': ['Procedure: Forced-air warming']}], 'interventions': [{'name': 'Forced-air warming', 'type': 'PROCEDURE', 'otherNames': ['Level 1 Snuggle Warm Upper Body Blanket', 'Forced-air warming blower'], 'description': 'In the intervention group a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the upper body of the patients laying on the operating table just beginning after the spinal block.', 'armGroupLabels': ['Active Warming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25421', 'city': 'Pinneberg', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management', 'geoPoint': {'lat': 53.65887, 'lon': 9.79698}}], 'overallOfficials': [{'name': 'Berthold Bein, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesiology', 'investigatorFullName': 'PD Dr. Jan Hoecker', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}