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

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:

Genetics Home Reference related topics: factor V Leiden thrombophilia prothrombin thrombophilia

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

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).

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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

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:

James AH. Venous thromboembolism in pregnancy. Arterioscler Thromb Vasc Biol. 2009 Mar;29(3):326-31. Review.

Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J; American College of Chest Physicians. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):844S-886S.

Morris JM, Algert CS, Roberts CL. Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. Epub 2010 Feb 1.

Sharma SK, Philip J, Wiley J. Thromboelastographic changes in healthy parturients and postpartum women. Anesth Analg. 1997 Jul;85(1):94-8.

Saha P, Stott D, Atalla R. Haemostatic changes in the puerperium '6 weeks postpartum' (HIP Study) - implication for maternal thromboembolism. BJOG. 2009 Nov;116(12):1602-12. Epub 2009 Aug 14.

Ng KF. Changes in thrombelastograph variables associated with aging. Anesth Analg. 2004 Aug;99(2):449-54, table of contents.

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 May 16, 2013