Thromboelastography in Non-elective Cesarean Delivery

NCT ID: NCT01514591

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Alex James Butwick

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alex Butwick, MBBS, FRCA

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Lucile Packard Children's Hospital

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21474664 (View on PubMed)

Other Identifiers

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IRB 22205

Identifier Type: OTHER

Identifier Source: secondary_id

SU-08162011-8270

Identifier Type: -

Identifier Source: org_study_id

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