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

May 11, 2013 updated by: PD Dr. Jan Hoecker, University Hospital Schleswig-Holstein

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

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Schleswig-Holstein
      • Pinneberg, Schleswig-Holstein, Germany, 25421
        • Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 minutes (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
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).
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:
  • Level 1 Snuggle Warm Upper Body Blanket
  • Forced-air warming blower

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
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
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.
20 min after child birth

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shivering incidence of the mothers
Time Frame: 20 min after child birth
Shivering of the mothers will be graded by a four-point scale.
20 min after child birth
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.
20 min after child birth
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.
20 min after child birth
Core temperature of the mothers
Time Frame: 20 min after child birth
Core temperature will be measured by a sublingual temperature probe.
20 min after child birth
Skin temperature of the mothers.
Time Frame: 20 min after child birth
Skin temperature of the mothers will be assessed at the chest.
20 min after child birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Berthold Bein, M.D., University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 11, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

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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