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Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06532266
Enrollment
120
Registered
2024-08-01
Start date
2023-11-01
Completion date
2026-06-30
Last updated
2024-08-01

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

Conditions

Newborn; Hyperthermia

Brief 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.

Interventions

DEVICETechTrade Ready Heat Half Body Temperature Management Blankets

The 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.

OTHERControl

3 layers of 100% cotton woven blankets

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Multiple pregnancy * Gestation \<37week or \>42 week * Placenta previa or abruptio placenta * Abnormal Cardiotocogram or fetal heart rate immediately prior to Caesarean section * Suspected or known fetal congenital abnormality * Immediate newborn condition that prevents STSC * Newborn birth weight \<2.5kg * Newborn rectal temperature \>38°C * Maternal tympanic temperature \>38°C

Design outcomes

Primary

MeasureTime frameDescription
Newborn hypothermiaafter 20 minutes of skin to skin contact after Caesarean delivery or at the cessation of using active or conventional warming method before completion of 20 minutes of STSC, whichever happens first.Body temperature below 36.5°C

Countries

China

Contacts

Primary ContactKa Wang Cheung, MD
kelvincheung82@hotmail.com22554567

Outcome results

None listed

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