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Temperature Study in Cesarean Section

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ClinicalTrials.gov Identifier: NCT01249014
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Edward Riley, Stanford University

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.


Condition or disease Intervention/treatment Phase
Cesarean Section Hypothermia Other: Warmed fluids Other: Fluid warmer and warming blanket Device: Belmont fluid warmer Device: Bair hugger warming blanket Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section
Actual Study Start Date : November 1, 2013
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : April 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
No Intervention: Control
No peri-operative warming.
Experimental: Warmed fluids
Patients will receive warmed i.v. fluids administered pre- and intra-operatively.
Other: Warmed fluids
IV fluids warmed by a Belmont fluid warmer

Device: Belmont fluid warmer
Belmont fluid warmer used to warm fluids

Experimental: Warmed fluids and warm air
Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.
Other: Warmed fluids
IV fluids warmed by a Belmont fluid warmer

Other: Fluid warmer and warming blanket
Warm are blown into a Bair hugger warming blanket covering the patient

Device: Belmont fluid warmer
Belmont fluid warmer used to warm fluids

Device: Bair hugger warming blanket
Bair hugger warming blanket laid on body




Primary Outcome Measures :
  1. temperature [ Time Frame: immediately prior to surgery upto 3hours post spinal anesthetic ]
    measured every 15 minutes from spinal anesthetic administration


Secondary Outcome Measures :
  1. Fetal pH [ Time Frame: Post partum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


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 ClinicalTrials.gov identifier (NCT number): NCT01249014


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Study Director: Edward Riley Stanford University
Sub-Investigator: Gill Hilton Stanford University
Principal Investigator: Pervez Sultan Stanford University

Responsible Party: Edward Riley, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01249014     History of Changes
Other Study ID Numbers: SU-11102010-7189
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms