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Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (THER5)

Primary Purpose

Thermoregulation Impairment, Hypothermia, Postoperative Shivering

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Forced-air warming
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thermoregulation Impairment focused on measuring Thermoregulation Impairment, hypothermia, Postoperative shivering, cesarean section, newborn

Eligibility Criteria

undefined - 20 Minutes (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control; passive insulation

Active Warming

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 12, 2013
Last Updated
May 11, 2013
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT01793558
Brief Title
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section
Acronym
THER5
Official Title
Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermoregulation Impairment, Hypothermia, Postoperative Shivering
Keywords
Thermoregulation Impairment, hypothermia, Postoperative shivering, cesarean section, newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control; passive insulation
Arm Type
No Intervention
Arm 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).
Arm Title
Active Warming
Arm Type
Experimental
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Forced-air warming
Other Intervention Name(s)
Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blower
Intervention 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.
Primary Outcome Measure Information:
Title
Body core temperature of the newborn
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.
Time Frame
20 min after birth
Secondary Outcome Measure Information:
Title
Skin temperature of the newborn
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.
Time Frame
20 min after child birth
Other Pre-specified Outcome Measures:
Title
Shivering incidence of the mothers
Description
Shivering of the mothers will be graded by a four-point scale.
Time Frame
20 min after child birth
Title
Thermal comfort of the mothers
Description
Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
Time Frame
20 min after child birth
Title
Mean arterial blood pressure of the mothers.
Description
Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
Time Frame
20 min after child birth
Title
Core temperature of the mothers
Description
Core temperature will be measured by a sublingual temperature probe.
Time Frame
20 min after child birth
Title
Skin temperature of the mothers.
Description
Skin temperature of the mothers will be assessed at the chest.
Time Frame
20 min after child birth

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Bein, M.D.
Organizational Affiliation
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
City
Pinneberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
25421
Country
Germany

12. IPD Sharing Statement

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Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

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