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Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00767832
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : November 9, 2009
Sponsor:
Information provided by:
Stanford University

Study Description
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Brief Summary:
The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

Condition or disease
Hemorrhage

Detailed Description:
The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) [ Time Frame: pre and post cesarean delivery ]

Secondary Outcome Measures :
  1. Hematologic indices

Biospecimen Retention:   None Retained
Venous blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
healthy pregnant patients undergoing elective cesarean delivery with spinal anesthesia.
Criteria

Inclusion Criteria:

  • All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Hospital who undergo elective Cesarean delivery.
  • We will select 100 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective Cesarean delivery, with no anticipated risk of obstetric hemorrhage.

Exclusion Criteria:

  • Patients with underlying coagulation disorders.
  • Patients with thrombocytopenia.
  • Patients with pregnancy-induced hypertension, pre-eclampsia.
  • Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
  • Patients requiring non-elective Cesarean delivery.
  • Patients with significant obstetric or medical disease.
  • No patients <18 years of age will be recruited.
Contacts and Locations
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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): NCT00767832


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Alexander J Butwick Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alex James Butwick, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00767832    
Other Study ID Numbers: SU-08252008-1287
11914
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: November 9, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes