Thromboelastometry Prediction Utility for Risk of Abortion

NCT03548701 | Completed

• 1 other identifier: GCO 18-0104
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Trimester, First; Abortion, Threatened

Keywords

Thromboelastometry; Vaginal Bleeding; Early Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Emergency Department

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

Diagnostic Test: Thromboelastometry testing

Obstetric Clinic

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

Diagnostic Test: Thromboelastometry testing

Interventions

Thromboelastometry testing DIAGNOSTIC_TEST

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

Emergency Department; Obstetric Clinic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded. Patients with ectopic pregnancies will also be excluded.

You may qualify if:

• 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.

You may not qualify if:

• Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded.
• Patients with ectopic pregnancies will also be excluded.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (5)

• 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. doi: 10.1016/j.ajog.2003.09.023.

  PMID: 15042008 BACKGROUND

• Harville EW, Wilcox AJ, Baird DD, Weinberg CR. Vaginal bleeding in very early pregnancy. Hum Reprod. 2003 Sep;18(9):1944-7. doi: 10.1093/humrep/deg379.

  PMID: 12923154 BACKGROUND

• 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. doi: 10.1093/humrep/deg494.

  PMID: 14645169 BACKGROUND

• 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.

  PMID: 24613698 BACKGROUND

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

  PMID: 21835606 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Whole blood collected at time of subject enrollment for thromboelastometry testing

MeSH Terms

Conditions

Abortion, Threatened; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick J Maher, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 7, 2018
• Study Start: June 4, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

US (1)