Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

NCT ID: NCT01793558

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

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.

Conditions

Thermoregulation Impairment; Hypothermia; Postoperative Shivering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Forced-air warming

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Level 1 Snuggle Warm Upper Body Blanket; Forced-air warming blower

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)

• Maximum Eligible Age: 20 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Jan Hoecker

Associate Professor of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Bein, M.D.

Role: STUDY_CHAIR

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

Locations

Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Pinneberg, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

THER-5

Identifier Type: -

Identifier Source: org_study_id