RecruitingNot ApplicableNCT06532266

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


Sponsor

The University of Hong Kong

Enrollment

120 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 10 YearsMax Age: 60 Years

Inclusion Criteria1

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

Exclusion Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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


Locations(1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06532266