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Clinical Trials/NCT01514591
NCT01514591
Completed
Not Applicable

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

Stanford University1 site in 1 country33 target enrollmentAugust 2011
ConditionsBleeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bleeding
Sponsor
Stanford University
Enrollment
33
Locations
1
Primary Endpoint
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
June 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alex James Butwick

Principal Investigator

Stanford University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)

Time Frame: pre and post cesarean delivery, an expected average of 75 minutes

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.

Secondary Outcomes

  • Hematologic indices(Pre and post cesarean delivery, an expected average of 75 minutes)

Study Sites (1)

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