Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Hypothermia Clinical Trial

— THER5  

Official title:

Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793558
• Other study ID #: THER-5
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: May 11, 2013
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 20 Minutes

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Postoperative Shivering
• Thermoregulation Impairment

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management	Pinneberg	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Shivering incidence of the mothers	Shivering of the mothers will be graded by a four-point scale.	20 min after child birth	No
Other	Thermal comfort of the mothers	Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.	20 min after child birth	No
Other	Mean arterial blood pressure of the mothers.	Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.	20 min after child birth	Yes
Other	Core temperature of the mothers	Core temperature will be measured by a sublingual temperature probe.	20 min after child birth	No
Other	Skin temperature of the mothers.	Skin temperature of the mothers will be assessed at the chest.	20 min after child birth	No
Primary	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	Yes
Secondary	Skin temperature of the newborn	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.	20 min after child birth	Yes