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NCT00767832 Clinical Trial

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

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00767832
Other study ID # SU-08252008-1287
Secondary ID 11914
Status Completed
Phase N/A
First received October 3, 2008
Last updated November 6, 2009
Start date August 2008
Est. completion date June 2009

Study information
Verified date November 2009
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) pre and post cesarean delivery No
Secondary Hematologic indices No
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