Clinical trial NCT01793558: Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section
Official title: Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thermoregulation Impairment
Hypothermia
Postoperative Shivering
Keywords: Thermoregulation Impairment
hypothermia
Postoperative shivering
cesarean section
newborn
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 40
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Body core temperature of the newborn
timeFrame: 20 min after birth
Secondary outcomes:
measure: Skin temperature of the newborn
timeFrame: 20 min after child birth
Other outcomes:
measure: Shivering incidence of the mothers
timeFrame: 20 min after child birth
measure: Thermal comfort of the mothers
timeFrame: 20 min after child birth
measure: Mean arterial blood pressure of the mothers.
timeFrame: 20 min after child birth
measure: Core temperature of the mothers
timeFrame: 20 min after child birth
measure: Skin temperature of the mothers.
timeFrame: 20 min after child birth
Locations:
city: Pinneberg
country: Germany
facility: Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
name: Berthold Bein, M.D.
role: STUDY_CHAIR
References: