Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Conditions
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Thermoregulation Impairment, Hypothermia, Postoperative Shivering

Intervention / Treatment
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* Procedure: Forced-air warming


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 20 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control; passive insulation<br>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<br>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<br>* 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.<br>* Other names: Forced-air warming blower;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body core temperature of the newborn | Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe. | 20 min after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature of the newborn | 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. | 20 min after child birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thermoregulation Impairment, hypothermia, Postoperative shivering, cesarean section, newborn