跳至主要内容
临床试验/NCT06532266
NCT06532266招募中不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Newborn hypothermia

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Newborn hypothermia

时间窗: after 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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