Thromboelastometry Prediction Utility for Risk of Abortion

Icahn School of Medicine at Mount Sinai98 enrolled

Overview

This study will use thromboelastometry in ED patients with vaginal bleeding, as well as healthy pregnant controls, to determine if abnormal results are associated with the presence of vaginal bleeding as well as later complications during pregnancy.

First, a case control study with samples collected from patients in the ED and OB clinic at Mount Sinai Hospital will be performed. Blood samples are being collected at time of study entry. Patient health history will be collected and blood samples will be tested using thromboelastometry in prospective fashion. Samples will be compared between groups. A prospective cohort will then be established using the subjects from the case control study. The purpose of this prospective cohort will be to collect outcomes of pregnancies to determine association with the initial thromboelastometry results.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy Trimester, First Abortion, Threatened

Interventions

Thromboelastometry testingDIAGNOSTIC_TEST

Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects will include pregnant women seen in the ED and OB clinic. The ED patients will include those seen for vaginal bleeding during pregnancy at less than 20 weeks gestation. OB Clinic patients will include those seen for first prenatal visit at which blood draw is performed, as long as this is also within 20 weeks estimated gestational age. Exclusion Criteria: * Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded. * Patients with ectopic pregnancies will also be excluded.

Locations (1)

Mount Sinai Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Maximum Clotting Firmness (MCF)

Thromboelastometry measurement of the Maximum Clot Firmness over the duration of the test. Performed as part of InTEM (response to ellagic acid) and ExTEM (response to tissue factor) measures.

Time frame: Day 1

Secondary Outcomes

Clot formation time (CFT)

Time to thromboelastometry measurement of the angle between formation of clot at 0mm and 20mm of strength. Performed as part of InTEM (response to ellagic acid) and ExTEM (response to tissue factor) measures.

Time frame: Day 1

Clotting Time (CT)

Thromboelastometry measurement of the time to first clot formation. Performed as part of InTEM (response to ellagic acid) and ExTEM (response to tissue factor) measures.

Time frame: Day 1

Pregnancy Outcome

Assessment of pregnancy outcome. Variable is treated as categorical and coded as spontaneous abortion, preterm labor, or term labor.

Time frame: Within 40 weeks of enrollment at completion of pregnancy

Number of Pregnancy Complications

Number of Pregnancy complications as a composite including pre-eclampsia, postpartum hemorrhage, or other clotting or bleeding dysfunction such as pulmonary embolus or preterm bleeding episodes.

Time frame: Within 40 weeks of enrollment at completion of pregnancy

Data from ClinicalTrials.gov

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