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Completed

NCT Number: NCT03548701

Thromboelastometry Prediction Utility for Risk of Abortion

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.

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Key information

Conditions

Pregnancy Trimester, First Abortion, Threatened Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thromboelastometry testing

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Acronym: TEMPURA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2018
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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