Thromboelastometry Prediction Utility for Risk of Abortion

Thromboelastometry Prediction Utility for Risk of Abortion

Sponsors

Lead sponsor: Icahn School of Medicine at Mount Sinai

Source 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.

Overall Status Completed
Start Date June 4, 2018
Completion Date May 15, 2019
Primary Completion Date May 15, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Maximum Clotting Firmness (MCF) Day 1
Secondary Outcome
Measure Time Frame
Clot formation time (CFT) Day 1
Clotting Time (CT) Day 1
Pregnancy Outcome Within 40 weeks of enrollment at completion of pregnancy
Number of Pregnancy Complications Within 40 weeks of enrollment at completion of pregnancy
Enrollment 98
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Thromboelastometry testing

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

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: Female

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Patrick J Maher, MD Principal Investigator Icahn School of Medicine at Mount Sinai
Location
facility Mount Sinai Hospital
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Icahn School of Medicine at Mount Sinai

Investigator full name: Patrick Maher

Investigator title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Emergency Department

Description: Patients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities.

Arm group label: Obstetric Clinic

Description: Patients with normal pregnancies being treated at first obstetric visit in clinic.

Acronym TEMPURA
Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov