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

Completed

• Conditions: Hemorrhage

• Registration Number: NCT00767832
• Lead Sponsor: Stanford University

Brief 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-06
• Last Update Posted: 2009-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)	pre and post cesarean delivery

Secondary Outcome Measures

Name	Time	Method
Hematologic indices

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States