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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616174
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Cesarean Delivery Procedure: Active warming with Bair Hugger blanket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Maternal Warming During Cesarean Delivery on Neonatal Temperature
Study Start Date : February 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Neonatal axillary temperature at delivery [ Time Frame: During delivery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616174

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Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
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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

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Responsible Party: University of British Columbia Identifier: NCT00616174    
Other Study ID Numbers: H07-01490
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Keywords provided by University of British Columbia:
Cesarean delivery
Active Warming
Neonatal Temperature