Thromboelastography in Non-elective Cesarean Delivery

Completed

• Conditions: Bleeding

• Registration Number: NCT01514591
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-23
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)	pre and post cesarean delivery, an expected average of 75 minutes	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

Name	Time	Method
Hematologic indices	Pre and post cesarean delivery, an expected average of 75 minutes	Hematologic indices will include: Hemoglobin concentration and platelet count.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Stanford, California, United States