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OpenTrials
Completed

NCT Number: NCT00767832

Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.

The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective 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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Hospital who undergo elective Cesarean delivery.
  • We will select 100 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective Cesarean delivery, with no anticipated risk of obstetric hemorrhage.

Exclusion criteria

  • Patients with underlying coagulation disorders.
  • Patients with thrombocytopenia.
  • Patients with pregnancy-induced hypertension, pre-eclampsia.
  • Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
  • Patients requiring non-elective Cesarean delivery.
  • Patients with significant obstetric or medical disease.
  • No patients <18 years of age will be recruited.

Treatment and study plan

Primary outcomes

  1. Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)

    Time frame: pre and post cesarean delivery

Secondary outcomes

  1. Hematologic indices

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 7, 2008
Registry last updated
Nov 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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