Thromboelastometry Prediction Utility for Risk of Abortion

Completed

• Conditions: Pregnancy Trimester, First; Abortion, Threatened
• Interventions: Diagnostic Test: Thromboelastometry testing

• Registration Number: NCT03548701
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-24
• Study Start: 2018-06-04
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-07
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emergency Department	Thromboelastometry testing	Patients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities.
Obstetric Clinic	Thromboelastometry testing	Patients with normal pregnancies being treated at first obstetric visit in clinic.

Primary Outcome Measures

Name	Time	Method
Maximum Clotting Firmness (MCF)	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

Name	Time	Method
Pregnancy Outcome	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.
Clot formation time (CFT)	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)	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.
Number of Pregnancy Complications	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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States