Thromboelastometry Prediction Utility for Risk of Abortion

Pregnancy Trimester, First Clinical Trial

— TEMPURA  

Official title:

Thromboelastometry Prediction Utility for Risk of Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548701
• Other study ID #: GCO 18-0104
• Status: Completed
• Start date: June 4, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Threatened
• Pregnancy Trimester, First

Intervention

Diagnostic Test:
• Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (5)

Armstrong S, Fernando R, Ashpole K, Simons R, Columb M. Assessment of coagulation in the obstetric population using ROTEM® thromboelastometry. Int J Obstet Anesth. 2011 Oct;20(4):293-8. doi: 10.1016/j.ijoa.2011.05.004. Epub 2011 Aug 10. — View Citation

Bennett SA, Bagot CN, Appiah A, Johns J, Ross J, Roberts LN, Patel RK, Arya R. Women with unexplained recurrent pregnancy loss do not have evidence of an underlying prothrombotic state: experience with calibrated automated thrombography and rotational thromboelastometry. Thromb Res. 2014 May;133(5):892-9. doi: 10.1016/j.thromres.2014.02.002. Epub 2014 Feb 11. — View Citation

Harville EW, Wilcox AJ, Baird DD, Weinberg CR. Vaginal bleeding in very early pregnancy. Hum Reprod. 2003 Sep;18(9):1944-7. — View Citation

Rai R, Tuddenham E, Backos M, Jivraj S, El'Gaddal S, Choy S, Cork B, Regan L. Thromboelastography, whole-blood haemostasis and recurrent miscarriage. Hum Reprod. 2003 Dec;18(12):2540-3. — View Citation

Weiss JL, Malone FD, Vidaver J, Ball RH, Nyberg DA, Comstock CH, Hankins GD, Berkowitz RL, Gross SJ, Dugoff L, Timor-Tritsch IE, D'Alton ME; FASTER Consortium. Threatened abortion: A risk factor for poor pregnancy outcome, a population-based screening study. Am J Obstet Gynecol. 2004 Mar;190(3):745-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Clotting Firmness (MCF)	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.	Day 1
Secondary	Clot formation time (CFT)	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.	Day 1
Secondary	Clotting Time (CT)	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.	Day 1
Secondary	Pregnancy Outcome	Assessment of pregnancy outcome. Variable is treated as categorical and coded as spontaneous abortion, preterm labor, or term labor.	Within 40 weeks of enrollment at completion of pregnancy
Secondary	Number of Pregnancy Complications	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.	Within 40 weeks of enrollment at completion of pregnancy