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Temperature Study in Cesarean Section

Primary Purpose

Cesarean Section, Hypothermia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Warmed fluids
Fluid warmer and warming blanket
Belmont fluid warmer
Bair hugger warming blanket
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:18-40 years. Healthy term (> 37 weeks) pregnant patients undergoing elective cesarean section with spinal anesthesia.

We will not discriminate with regard to ethnic background. ASA 1 and 2 patients scheduled for elective cesarean sections under spinal anesthesia at LPCH.

Exclusion Criteria:Not ASA 1 or 2 Not spinal anesthetic

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Warmed fluids

Warmed fluids and warm air

Arm Description

No peri-operative warming.

Patients will receive warmed i.v. fluids administered pre- and intra-operatively.

Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.

Outcomes

Primary Outcome Measures

temperature
measured every 15 minutes from spinal anesthetic administration

Secondary Outcome Measures

Fetal pH

Full Information

First Posted
November 23, 2010
Last Updated
June 6, 2018
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01249014
Brief Title
Temperature Study in Cesarean Section
Official Title
Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2013 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being infused, and of warm air blown into a blanket covering the body. The control group will not have any active warming methods. Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative period. Study group 2 will have a forced-air warmer in the intra-operative period as well as the fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital signs following delivery.
Detailed Description
Potential participants will be approached by a member of the research team prior to surgery. Patients will be fully informed of the study by a study investigator, full written informed consent will be obtained. We will recruit healthy ASA 1 and 2 patients undergoing uncomplicated elective cesarean sections. Patients will be randomised into one of three groups. Control group will have no active warming. Study group 1 will have pre- and intraoperative intravenous fluid warming. Study group 2 will have the same as study group 1 but with additional intraoperative warming air blown into a blanket covering the body. Temperature measurements will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery. At the same time as temperature monitoring the patients will be assessed for shivering (4 point scale) and will be asked their comfort level with regard to their temperature (5 point scale). We will record vital signs (measured routinely by the pediatricians at cesarean delivery) from the neonate immediately following delivery. Samples of blood will be taken from the placental cord following delivery to measure cord blood gas results. We will carry out a chart review looking at the success rate of breast feeding (if applicable). We are studying the effect of intravenous fluid warming and forced-air warming on your body temperature at the time of your cesarean section. Perioperative hypothermia can have adverse affects on your health and recovery following surgery so the aim of this study is to find ways to prevent or reduce the incidence of hypothermia. Participants will be randomized into one of three groups. The control group will not receive any perioperative warming. Study group 1 will have intravenous fluids warmed. Study group 2 will be the same as group 1 with the addition of a forced-air warmer in the operating room. Your temperature will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery. At the time of the temperature measurements we will also assess any shivering you may have and also question you regarding how warm/cold you feel. Following delivery of the placenta we will send one blood sample taken from the placental cord to the biochemistry laboratory for analysis of the cord blood gases. The blood sample will not be stored for future studies. We will be observing the vital signs of the neonate immediately following delivery. We will be carrying out a chart review looking at the success rate of breast feeding (if applicable).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Hypothermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No peri-operative warming.
Arm Title
Warmed fluids
Arm Type
Experimental
Arm Description
Patients will receive warmed i.v. fluids administered pre- and intra-operatively.
Arm Title
Warmed fluids and warm air
Arm Type
Experimental
Arm Description
Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.
Intervention Type
Other
Intervention Name(s)
Warmed fluids
Intervention Description
IV fluids warmed by a Belmont fluid warmer
Intervention Type
Other
Intervention Name(s)
Fluid warmer and warming blanket
Intervention Description
Warm are blown into a Bair hugger warming blanket covering the patient
Intervention Type
Device
Intervention Name(s)
Belmont fluid warmer
Intervention Description
Belmont fluid warmer used to warm fluids
Intervention Type
Device
Intervention Name(s)
Bair hugger warming blanket
Intervention Description
Bair hugger warming blanket laid on body
Primary Outcome Measure Information:
Title
temperature
Description
measured every 15 minutes from spinal anesthetic administration
Time Frame
immediately prior to surgery upto 3hours post spinal anesthetic
Secondary Outcome Measure Information:
Title
Fetal pH
Time Frame
Post partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:18-40 years. Healthy term (> 37 weeks) pregnant patients undergoing elective cesarean section with spinal anesthesia. We will not discriminate with regard to ethnic background. ASA 1 and 2 patients scheduled for elective cesarean sections under spinal anesthesia at LPCH. Exclusion Criteria:Not ASA 1 or 2 Not spinal anesthetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Riley
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gill Hilton
Organizational Affiliation
Stanford University
Official's Role
Sub-Investigator
First Name & Middle Initial & Last Name & Degree
Pervez Sultan
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Temperature Study in Cesarean Section

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