Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

NCT01793558 | Completed

• 1 other identifier: THER-5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thermoregulation Impairment; Hypothermia; Postoperative Shivering

Keywords

Thermoregulation Impairment; hypothermia; Postoperative shivering; cesarean section; newborn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skin temperature of the newborn

  20 min after child birth

Other Outcomes (5)

• Shivering incidence of the mothers

  20 min after child birth

• Thermal comfort of the mothers

  20 min after child birth

• Mean arterial blood pressure of the mothers.

  20 min after child birth

Study Arms (2)

Control; passive insulation

NO INTERVENTION

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).

Active Warming

EXPERIMENTAL

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

Interventions

Forced-air warming PROCEDURE

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.

Also known as: Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blower

Active Warming

Eligibility Criteria

• Age: Up to 20 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• parturients undergoing planned, elective cesarean section under spinal anaesthesia
• mothers classified as American Society of Anaesthesiologists (ASA) status I or II
• written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Pinneberg, Schleswig-Holstein, 25421, Germany

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berthold Bein, M.D.

  University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesiology

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

DE (1)