Thromboelastography in Non-elective Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alex James Butwick, Stanford University
ClinicalTrials.gov Identifier:
NCT01514591
First received: January 11, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition
Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) [ Time Frame: pre and post cesarean delivery, an expected average of 75 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Hematologic indices [ Time Frame: Pre and post cesarean delivery, an expected average of 75 minutes ] [ Designated as safety issue: No ]
    Hematologic indices will include: Hemoglobin concentration and platelet count.


Biospecimen Retention:   Samples With DNA

Blood samples for TEG analysis.


Enrollment: 33
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-elective Cesarean Delivery
We will only enroll patients undergoing non-elective CS with an 'epidural top-up' for surgical anesthesia. By definition, our study will only apply to laboring women with working labor epidurals (which were provided for labor analgesia).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obstetrical laboring patients who are undergoing non-elective Cesarean delivery with an 'epidural top up' for surgical anesthesia.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01514591

Locations
United States, California
Lucile Packard Children's Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Alex Butwick, MBBS, FRCA Stanford University
  More Information

Publications:
Responsible Party: Alex James Butwick, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01514591     History of Changes
Other Study ID Numbers: SU-08162011-8270, IRB 22205
Study First Received: January 11, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014