A Randomised Controlled Trial Using Active Warming in Prevention of Newborn Hypothermia After Caesarean Delivery Without Interruption to Skin-to-skin Contact

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 60
Healthy Volunteers: f
View:

• All women scheduled for elective Caesarean section under spinal anaesthesia during study period.

Locations
Other Locations
China
Department of Obstetrics and Gynaecology
RECRUITING
Hong Kong
Contact Information
Primary
Ka Wang Cheung, MD
kelvincheung82@hotmail.com
22554567
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Intervention
Placebo_comparator: Control
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov