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Thromboelastometry Prediction Utility for Risk of Abortion (TEMPURA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03548701
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick Maher, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date May 24, 2018
First Posted Date June 7, 2018
Last Update Posted Date June 1, 2020
Actual Study Start Date June 4, 2018
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thromboelastometry Prediction Utility for Risk of Abortion
Official Title Thromboelastometry Prediction Utility for Risk of Abortion
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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Whole blood collected at time of subject enrollment for thromboelastometry testing
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.
Condition
  • Pregnancy Trimester, First
  • Abortion, Threatened
Intervention Diagnostic Test: Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
Study Groups/Cohorts
  • Emergency Department
    Patients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities.
    Intervention: Diagnostic Test: Thromboelastometry testing
  • Obstetric Clinic
    Patients with normal pregnancies being treated at first obstetric visit in clinic.
    Intervention: Diagnostic Test: Thromboelastometry testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2020)
98
Original Estimated Enrollment
 (submitted: June 5, 2018)
80
Actual Study Completion Date May 15, 2019
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03548701
Other Study ID Numbers GCO 18-0104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Patrick Maher, Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators Not Provided
Investigators
Principal Investigator: Patrick J Maher, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2020