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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01416454
First received: August 11, 2011
Last updated: March 20, 2013
Last verified: March 2013
  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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    • 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

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01416454     History of Changes
Other Study ID Numbers: SU-11192010-7216, 19878
Study First Received: August 11, 2011
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014