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Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01793558
Acronym
THER5
Enrollment
40
Registered
2013-02-15
Start date
2013-02-28
Completion date
2013-04-30
Last updated
2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Postoperative Shivering, Thermoregulation Impairment

Keywords

Thermoregulation Impairment, hypothermia, Postoperative shivering, cesarean section, newborn

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.

Interventions

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.

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 20 Minutes
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Body core temperature of the newborn20 min after birthCore temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.

Secondary

MeasureTime frameDescription
Skin temperature of the newborn20 min after child birthSkin 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.

Other

MeasureTime frameDescription
Thermal comfort of the mothers20 min after child birthThermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
Mean arterial blood pressure of the mothers.20 min after child birthMean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
Skin temperature of the mothers.20 min after child birthSkin temperature of the mothers will be assessed at the chest.
Core temperature of the mothers20 min after child birthCore temperature will be measured by a sublingual temperature probe.
Shivering incidence of the mothers20 min after child birthShivering of the mothers will be graded by a four-point scale.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026