Status:
COMPLETED
Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia
Lead Sponsor:
Aliona Vilinsky-Redmond
Conditions:
Neonatal Hypothermia
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS). Specifically, there is a l...
Detailed Description
Peri-operative active warming is the practice of warming patients who undergo an operation with the use of one or more warming devices. Active warming can be initiated before, during and/or after an o...
Eligibility Criteria
Inclusion
- In order for women and their new-borns to be eligible to participate in the study they should be;
- Aged 18 years or over
- Able to provide informed consent for themselves and their babies
- Who have a singleton pregnancy between 37+0 and 41+6 weeks gestation
- Whose foetus/new-born is alive/born alive, and has no risk factors such as congenital or cardiovascular anomalies (see Appendix 2, TSRF)
- Who receive spinal or combined spinal anaesthesia for their caesarean section
- Have an elective CS
- Who are willing and able to perform skin-to-skin contact
Exclusion
- Women will be excluded from this study if they;
- Have pyrexia (\> 37.5C on admission to ward)
- Have a maternal medical disease (ie. Spinal abnormalities, coagulation abnormalities, maternal serology positive, congestive heart failure, severe renal function impairment)
- Have general anaesthesia
- Have a baby who has a congenital anomaly (ie. Spina bifida, anencephaly, hydrocephaly, cardiovascular anomalies, anomalies of nervous system, defects of anterior abdominal wall)
- Have a baby who has abnormal Doppler artery velocimetry
- Have a stillbirth baby
- Have a recent USS estimating the fetal weight less than 2000g
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03316716
Start Date
January 24 2018
End Date
May 31 2018
Last Update
June 15 2018
Active Locations (1)
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1
Rotunda Hospital
Dublin, Ireland, Dublin 1