NCT03548701

Thromboelastometry Prediction Utility for Risk of Abortion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy Trimester, First
• Abortion, Threatened

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Thromboelastometry testing	Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities

Timeline

• Start date: 2018-06-04
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2018-06-07
• Last updated: 2020-06-01

Locations

1 site across 1 country: United States