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Thromboelastometry Prediction Utility for Risk of Abortion (TEMPURA)

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ClinicalTrials.gov Identifier: NCT03548701
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Maher, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy Trimester, First Abortion, Threatened Diagnostic Test: Thromboelastometry testing

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Thromboelastometry Prediction Utility for Risk of Abortion
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : May 21, 2020
Estimated Study Completion Date : May 21, 2020

Group/Cohort Intervention/treatment
Emergency Department
Patients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities.
Diagnostic Test: Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities

Obstetric Clinic
Patients with normal pregnancies being treated at first obstetric visit in clinic.
Diagnostic Test: Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities




Primary Outcome Measures :
  1. Maximum Clotting Firmness (MCF) [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Clot formation time (CFT) [ Time Frame: Day 1 ]
    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.

  2. Clotting Time (CT) [ Time Frame: Day 1 ]
    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.

  3. Pregnancy Outcome [ Time Frame: Within 40 weeks of enrollment at completion of pregnancy ]
    Assessment of pregnancy outcome. Variable is treated as categorical and coded as spontaneous abortion, preterm labor, or term labor.

  4. Number of Pregnancy Complications [ Time Frame: Within 40 weeks of enrollment at completion of pregnancy ]
    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.


Biospecimen Retention:   None Retained
Whole blood collected at time of subject enrollment for thromboelastometry testing


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded. Patients with ectopic pregnancies will also be excluded.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548701


Contacts
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Contact: Patrick J Maher, MD 404-550-9559 patrick.maher@mountsinai.org
Contact: Daniel Katz, MD 732-322-6675 daniel.katz@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Patrick Maher, MD    404-550-9559    patrick.maher@mountsinai.org   
Contact: Daniel Katz, MD    732-322-6675    daniel.katz@mountsinai.org   
Principal Investigator: Patrick Maher, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Patrick J Maher, MD Icahn School of Medicine at Mount Sinai

Publications:
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Responsible Party: Patrick Maher, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03548701     History of Changes
Other Study ID Numbers: GCO 18-0104
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Maher, Icahn School of Medicine at Mount Sinai:
Thromboelastometry
Vaginal Bleeding
Early Pregnancy

Additional relevant MeSH terms:
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Abortion, Threatened
Pregnancy Complications