Clinical trial NCT01514591: Thromboelastography in Non-elective Cesarean Delivery
Official title: Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)
timeFrame: pre and post cesarean delivery, an expected average of 75 minutes
Secondary outcomes:
measure: Hematologic indices
timeFrame: Pre and post cesarean delivery, an expected average of 75 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Alex Butwick, MBBS, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.