Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Not Applicable

Completed

• Conditions: Thermoregulation Impairment; Hypothermia; Postoperative Shivering
• Interventions: Procedure: Forced-air warming

• Registration Number: NCT01793558
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-11
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Warming	Forced-air 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).

Primary Outcome Measures

Name	Time	Method
Body core temperature of the newborn	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.

Secondary Outcome Measures

Name	Time	Method
Skin temperature of the newborn	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.

Trial Locations

Locations (1)

Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management; 🇩🇪 Pinneberg, Schleswig-Holstein, Germany