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Completed

NCT Number: NCT01514591

Thromboelastography in Non-elective Cesarean Delivery

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Hematologic indices

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

    Hematologic indices will include: Hemoglobin concentration and platelet count.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2012
Registry last updated
Jun 21, 2013

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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