Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (THER5)
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|ClinicalTrials.gov Identifier: NCT01793558|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Thermoregulation Impairment Hypothermia Postoperative Shivering||Procedure: Forced-air warming||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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).
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).
Procedure: Forced-air warming
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.
- Body core temperature of the newborn [ Time Frame: 20 min after birth ]Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
- Skin temperature of the newborn [ Time Frame: 20 min after child birth ]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.
- Shivering incidence of the mothers [ Time Frame: 20 min after child birth ]Shivering of the mothers will be graded by a four-point scale.
- Thermal comfort of the mothers [ Time Frame: 20 min after child birth ]Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
- Mean arterial blood pressure of the mothers. [ Time Frame: 20 min after child birth ]Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
- Core temperature of the mothers [ Time Frame: 20 min after child birth ]Core temperature will be measured by a sublingual temperature probe.
- Skin temperature of the mothers. [ Time Frame: 20 min after child birth ]Skin temperature of the mothers will be assessed at the chest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793558
|Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management|
|Pinneberg, Schleswig-Holstein, Germany, 25421|
|Study Chair:||Berthold Bein, M.D.||University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany|