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

NCT ID: NCT06532266

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-06-30

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.

Conditions

Newborn; Hyperthermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Group Type: ACTIVE_COMPARATOR

TechTrade Ready Heat Half Body Temperature Management Blankets

Intervention Type: DEVICE

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.

Control

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

3 layers of 100% cotton woven blankets

Interventions

TechTrade 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.

Intervention Type: DEVICE

Control

3 layers of 100% cotton woven blankets

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ka Wang Cheung, MD

Role: STUDY_DIRECTOR

The University of Hong Kong

Locations

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ka Wang Cheung, MD

Role: CONTACT

kelvincheung82@hotmail.com

22554567

Facility Contacts

Ka Wang Cheung

Role: primary

kelvincheung82@hotmail.com

(852) 22553111

Other Identifiers

UW 22-695

Identifier Type: -

Identifier Source: org_study_id