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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jan Hoecker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01793558
First received: February 12, 2013
Last updated: May 11, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Thermoregulation Impairment
Hypothermia
Postoperative Shivering
 Procedure: Forced-air warming

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Body core temperature of the newborn [ Time Frame: 20 min after birth ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 20 min after child birth ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Shivering incidence of the mothers [ Time Frame: 20 min after child birth ] [ Designated as safety issue: No ]
    Shivering of the mothers will be graded by a four-point scale.

  • Thermal comfort of the mothers [ Time Frame: 20 min after child birth ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Core temperature will be measured by a sublingual temperature probe.

  • Skin temperature of the mothers. [ Time Frame: 20 min after child birth ] [ Designated as safety issue: No ]
    Skin temperature of the mothers will be assessed at the chest.


Enrollment: 40
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Level 1 Snuggle Warm Upper Body Blanket
  • Forced-air warming blower

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.

  Eligibility

Ages Eligible for Study:   up to 20 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793558

Locations
Germany
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
Pinneberg, Schleswig-Holstein, Germany, 25421
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Berthold Bein, M.D. University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
  More Information

No publications provided

Responsible Party: PD Dr. Jan Hoecker, Associate Professor of Anaesthesiology, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01793558     History of Changes
Other Study ID Numbers: THER-5
Study First Received: February 12, 2013
Last Updated: May 11, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University of Schleswig-Holstein:
Thermoregulation Impairment
hypothermia
Postoperative shivering
cesarean section
newborn

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013