- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767832
Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.
November 6, 2009 updated by: Stanford University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
healthy pregnant patients undergoing elective cesarean delivery with spinal anesthesia.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)
Time Frame: pre and post cesarean delivery
|
pre and post cesarean delivery
|
Secondary Outcome Measures
Outcome Measure |
---|
Hematologic indices
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander J Butwick, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
October 3, 2008
First Submitted That Met QC Criteria
October 6, 2008
First Posted (Estimate)
October 7, 2008
Study Record Updates
Last Update Posted (Estimate)
November 9, 2009
Last Update Submitted That Met QC Criteria
November 6, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-08252008-1287
- 11914
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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