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

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Postoperative Shivering; Thermoregulation Impairment; Hypothermia

Treatments: Procedure: Forced-air warming

Study type: Interventional

Funder types: Other

Identifiers

NCT01793558

THER-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 20 minutes old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control; passive insulation

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Procedure: Forced-air warming