- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793558
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (THER5)
Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
Therefore, 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Schleswig-Holstein
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Pinneberg, Schleswig-Holstein, Germany, 25421
- Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- parturients undergoing planned, elective cesarean section under spinal anaesthesia
- mothers classified as American Society of Anaesthesiologists (ASA) status I or II
- written informed consent
Exclusion Criteria:
- mothers younger than 18 years
- mothers classified as American Society of Anaesthesiologists (ASA) status III or higher
- caesarean section planned under general anaesthesia.
any expected problems with the newborn such as:
- gestation date < 36 or > 42 week
- placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control; passive insulation
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).
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Experimental: Active Warming
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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body core temperature of the newborn
Time Frame: 20 min after birth
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Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
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20 min after birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin temperature of the newborn
Time Frame: 20 min after child birth
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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.
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20 min after child birth
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shivering incidence of the mothers
Time Frame: 20 min after child birth
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Shivering of the mothers will be graded by a four-point scale.
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20 min after child birth
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Thermal comfort of the mothers
Time Frame: 20 min after child birth
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Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
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20 min after child birth
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Mean arterial blood pressure of the mothers.
Time Frame: 20 min after child birth
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Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
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20 min after child birth
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Core temperature of the mothers
Time Frame: 20 min after child birth
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Core temperature will be measured by a sublingual temperature probe.
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20 min after child birth
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Skin temperature of the mothers.
Time Frame: 20 min after child birth
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Skin temperature of the mothers will be assessed at the chest.
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20 min after child birth
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Collaborators and Investigators
Investigators
- Study Chair: Berthold Bein, M.D., University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THER-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Forced-air warming
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Medical University of ViennaSuspendedHypothermia | PolytraumaAustria
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Hacettepe UniversityCigdem Yucel; Ozgur OzyuncuActive, not recruitingCesarean Section Complications | HypothermiaTurkey
-
Dokuz Eylul UniversityCompletedSurgical Site Infection
-
Indus Hospital and Health NetworkUnknownForced Air Warming Effect on HypothermiaPakistan
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Virginia Commonwealth UniversityRecruitingCesarean SectionUnited States
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Medical University of ViennaCompleted
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The University of Texas Health Science Center,...RecruitingHypothermia; Anesthesia | Hypothermia, Newborn | Hypothermia, SequelaUnited States
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Vanderbilt UniversityWithdrawnCesarean SectionUnited States
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Hacettepe UniversityCompletedTemperature Change, BodyTurkey
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Mahidol UniversityCompletedHypothermia | Vascular Surgery | Forced-air Warming Mattress | Circulating-water MattressThailand