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

January 11, 2012
June 19, 2013
August 2011
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01514591 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Thromboelastography in Non-elective Cesarean Delivery
Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples for TEG analysis.

Non-Probability Sample

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

Bleeding
Not Provided
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).
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514591
SU-08162011-8270, IRB 22205
Yes
Alex James Butwick, Stanford University
Stanford University
Not Provided
Principal Investigator: Alex Butwick, MBBS, FRCA Stanford University
Stanford University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP