Does Warming Mothers During Cesarean Delivery Help Keep Babies Warm When Delivered? - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00616174

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

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Maternal Warming During Cesarean Delivery on Neonatal Temperature

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 ]

Estimated Enrollment:	70
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	June 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.

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

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 ( Dr. Roanne Preston )
Study ID Numbers:	H07-01490, H07-01490
Study First Received:	February 5, 2008
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00616174 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Cesarean delivery
Active Warming
Neonatal Temperature

Study placed in the following topic categories:

Anesthetics

ClinicalTrials.gov processed this record on May 07, 2009