Actively Recruiting
Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery
Led by The University of Hong Kong · Updated on 2024-08-01
120
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Despite the enormous advantages that skin-to-skin contact (STSC) and Delaying Cord Clamping (DCC) bring, newborns can lose heat quickly if they are not thermally protected. In the first 10-20 minutes after birth, newborns can experience a body temperature drop of between 2°C to 4°C if they are not properly dried and covered. In 2014, Horn et al. published a research paper regarding the incidence and prevention of newborn hypothermia after Caesarean delivery. The findings showed up to 80% of newborns become hypothermic if only warm towels (passive insulation) were used during STSC after Caesarean delivery. Evidence also shows higher hypothermia rates in infants born by Caesarean section than vaginal birth. STSC will begin while Caesarean section continues. Newborns will be clothed in a cotton hat and diaper. Newborns will be placed on bare chest of mother, horizontally, in prone position. The head of the newborn will turn laterally, making the nose and mouth unobstructed. Newborns' hands are not swaddled and are free to move to allow exploration to facilitate first feeding. In both groups, infants will be covered from head-to-toe with 3 layers of 100% cotton woven blankets, taken from a 70°C heating cabinet. For the "intervention group", thermal blanket will be placed on top of the cotton blanket. Newborn will be first covered with conventional warm blanket then adding the thermal blanket on top. The thermal blanket will be placed inside a "pillowcase" like cotton blanket to avoid direct contact with mother or newborn.
CONDITIONS
Official Title
Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women scheduled for elective Caesarean section under spinal anesthesia during the study period
You will not qualify if you...
- Multiple pregnancy
- Gestation less than 37 weeks or more than 42 weeks
- Placenta previa or abruptio placenta
- Abnormal cardiotocogram or fetal heart rate immediately before Caesarean section
- Suspected or known fetal congenital abnormality
- Newborn conditions preventing skin-to-skin contact including birth weight under 2.5 kg, newborn rectal temperature above 38°C, or maternal tympanic temperature above 38°C
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China, 852
Actively Recruiting
Research Team
K
Ka Wang Cheung, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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