Does Warming Mothers During Cesarean Delivery Help Keep Babies Warm When Delivered?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00616174
First received: February 5, 2008
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The purpose of this study to investigate whether using a special warming blanket during Cesarean delivery helps maintain a normal body temperature in the baby when compared to mothers that are not warmed (standard care at BC Women's Hospital). Doctors observed that some babies have low body temperatures when they are born by Cesarean delivery. Since baby temperatures are dependant on the temperatures of their mothers, we believe that keeping the mother warm during surgery with the use of a special warming blanket that is filled with warm air will result in the baby being warmer at birth.


Condition Intervention
Cesarean Delivery
Procedure: Active warming with Bair Hugger blanket

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Maternal Warming During Cesarean Delivery on Neonatal Temperature

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Neonatal axillary temperature at delivery [ Time Frame: During delivery ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Active warming with Bair Hugger blanket
Procedure: Active warming with Bair Hugger blanket
Standard care at BC Women's Hospital plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C). Warming will continue until the end of surgery unless otherwise requested by the mother.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All women undergoing elective cesarean delivery under spinal anesthesia or combined spinal epidural anesthesia
  • Greater than 28 weeks gestation
  • ASA 1 & 2 classification of health
  • Mothers presenting to the assessment or labour and delivery unit with ruptured membranes or early signs of labour, but not in active labour, who are not planned for a vaginal birth and who need an urgent cesarean delivery
  • Potential subjects need to be able to read and understand English unless independent (non-partner) translator available

Exclusion Criteria:

  • Mothers in active labour - 3cm or more dilated with regular coordinated contractions
  • ASA 3 or above
  • Emergency cesarean delivery for fetal heart rate abnormalities
  • Cesarean delivery under general anesthesia
  • Maternal age <19 years
  • Maternal infection
  • Mothers with a CSE where > 5ml of epidural local anesthetic is given prior to the delivery of the fetus
  • Mothers with vascular disease - with the exception of hypertension/pre-eclampsia
  • Mothers with Type I Diabetes Mellitus
  • Untreated hypothyroidism or hyperthyroidism
  • Mothers with a history or family history of malignant hyperthermia
  • Those who cannot understand English, and lack of consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616174

Locations
Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Preston Roanne, MD University of British Columbia
Study Director: Joanne Douglas, MD, FRCPC University of British Columbia
Study Director: Jason Reidy, MBBS, FRCA University of British Columbia
Study Director: Simon Massey, MB BCh, MRCP, FRCA University of British Columbia
Study Director: Rebecca Sherlock, MD, FRCPC, FAAP, PhD University of British Columbia
Study Director: Jessica Tyler, BSc University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00616174     History of Changes
Other Study ID Numbers: H07-01490, H07-01490
Study First Received: February 5, 2008
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Cesarean delivery
Active Warming
Neonatal Temperature

ClinicalTrials.gov processed this record on August 26, 2014