Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Body core temperature of the newborn
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 20 Minutes (Child)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Body core temperature of the newborn
Time Frame: 20 min after birth
Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
Secondary Outcomes
- Skin temperature of the newborn(20 min after child birth)
Investigators
PD Dr. Jan Hoecker
Associate Professor of Anaesthesiology
University Hospital Schleswig-Holstein