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Thromboelastography to Assess Age-Related Coagulation Differences in Patients Undergoing Cesarean Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416454
First Posted: August 15, 2011
Last Update Posted: March 22, 2013
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.
Information provided by (Responsible Party):
Stanford University
  Purpose
The purpose of the study is to assess potential age-related differences on coagulation profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The investigators will compare coagulation data collected from the study to assess potential differences in coagulation parameters for the following age groups: (i) women less than 35 yrs (ii) women 35 yrs or older.

Condition
Thrombophilia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboelastography to Assess Age-Related Coagulation Differences in Patients Undergoing Elective Cesarean Delivery.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Thromboelastography parameters [ Time Frame: 3 days ]

    Thromboelastography parameters include:

    Reaction (r) time Clot Formation (k) time Alpha Angle Maximum Amplitude (MA) Time to maximum rate of thrombus generation (Tmax) Maximum rate of thrombus generation (MRTG) Total Thrombus generated (TTG)



Secondary Outcome Measures:
  • laboratory coagulation parameters [ Time Frame: 3 days ]
    • Prothrombin time
    • Activated partial thromboplastin time
    • Fibrinogen level.


Enrollment: 46
Study Start Date: October 2010
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elective Cesarean delivery, age <35 yrs
Women undergoing elective cesarean delivery with a spinal anesthetic who are less than 35 y of age (at the time of delivery).
Elective Cesarean delivery, age =>35 yrs
Women undergoing elective Cesarean delivery with a spinal anesthetic who are => 35 yrs of age (at the time of delivery).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Our study population will be obstetric patients undergoing delivery on the labor and delivery unit at Lucile Packard Children's Hospital (LPCH).
Criteria

Inclusion Criteria:

  • All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at LPCH who undergo elective Cesarean delivery with neuraxial anesthesia.
  • We will enroll only healthy patients with singleton pregnancies and whose pregnancy is not result of in vitro fertilization.

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: non-steroidal anti-inflammatories, 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
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): NCT01416454


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01416454     History of Changes
Other Study ID Numbers: SU-11192010-7216
19878 ( Registry Identifier: Stanford University )
First Submitted: August 11, 2011
First Posted: August 15, 2011
Last Update Posted: March 22, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases