Actively Recruiting

Phase Not Applicable
Age: 10Years - 60Years
FEMALE
NCT06532266

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

Age: 10Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women scheduled for elective Caesarean section under spinal anesthesia during the study period
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China, 852

Actively Recruiting

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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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