Thromboelastography in Non-elective Cesarean Delivery

Bleeding Clinical Trial

Official title:

Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514591
• Other study ID #: SU-08162011-8270
• Secondary ID: IRB 22205
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: June 19, 2013
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• 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 laboring patients undergoing non-elective (intrapartum)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 laboring patients undergoing non-elective (intrapartum)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: 33
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Obstetric in-patients

• Laboring patients with Epidurals for Labor Analgesia going for non-elective Cesarean

• Patients of all ethnic backgrounds will be included

• Singleton pregnancy

• ASA 1 or 2

Exclusion Criteria:

• Patients with underlying coagulation disorders.

• Patients with thrombocytopenia (platelet count <100).

• Patients with pregnancy-induced hypertension, pre-eclampsia.

• Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.

• Patients requiring 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

• Bleeding

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)	This study will allow us to collect more information about the hemostatic effects that occur during non-elective Cesarean delivery. This information will add to current knowledge base (which we have published) about coagulation changes in the peripartum period in patients undergoing non-elective Cesarean section.	pre and post cesarean delivery, an expected average of 75 minutes	No
Secondary	Hematologic indices	Hematologic indices will include: Hemoglobin concentration and platelet count.	Pre and post cesarean delivery, an expected average of 75 minutes	No