Thromboelastometry Prediction Utility for Risk of Abortion



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:6/9/2018
Start Date:June 4, 2018
End Date:May 21, 2020
Contact:Patrick J Maher, MD
Email:patrick.maher@mountsinai.org
Phone:404-550-9559

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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.

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.
We found this trial at
1
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New York, New York 10029
Principal Investigator: Patrick Maher, MD
Phone: 404-550-9559
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