Thromboelastography in Non-elective Cesarean Delivery

NCT01514591 | Completed DMC

• 2 other identifiers: SU-08162011-8270IRB 22205
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hematologic indices

  Pre and post cesarean delivery, an expected average of 75 minutes

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 21474664 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for TEG analysis.

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex Butwick, MBBS, FRCA

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 23, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

US (1)