Does Warming Mothers During Cesarean Delivery Help Keep Babies Warm When Delivered?
This study is ongoing, but not recruiting participants.
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00616174
First received: February 5, 2008
Last updated: October 4, 2011
Last verified: October 2011
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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 ]
| Estimated Enrollment: | 70 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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
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: | October 4, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Cesarean delivery Active Warming Neonatal Temperature |
ClinicalTrials.gov processed this record on May 21, 2013