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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00767832
First received: October 3, 2008
Last updated: November 6, 2009
Last verified: November 2009
History of Changes
  Purpose

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
Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) [ Time Frame: pre and post cesarean delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematologic indices [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Venous blood


Estimated Enrollment: 60
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767832

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Alexander J Butwick Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alex James Butwick, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00767832     History of Changes
Other Study ID Numbers: SU-08252008-1287, 11914
Study First Received: October 3, 2008
Last Updated: November 6, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013