NCT00616174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

February 5, 2008

Last Update Submit

March 14, 2014

Conditions

Cesarean Delivery

Keywords

Cesarean deliveryActive WarmingNeonatal Temperature

Outcome Measures

Primary Outcomes (1)

  • Neonatal axillary temperature at delivery

    During delivery

Study Arms (1)

1

OTHER

Active warming with Bair Hugger blanket

Procedure: Active warming with Bair Hugger blanket

Interventions

Active warming with Bair Hugger blanketPROCEDURE

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.

1

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, Canada

Location

Study Officials

  • Preston Roanne, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

CA(1)