Thromboelastography in Non-elective Cesarean Delivery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01514591

Enrollment

Registered

2012-01-23

Start date

2011-08-31

Completion date

2013-06-30

Last updated

2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results