Thromboelastometry Prediction Utility for Risk of Abortion
NCT ID: NCT03548701
Last Updated: 2020-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
98 participants
OBSERVATIONAL
2018-06-04
2019-05-15
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Emergency Department
Patients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities.
Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
Obstetric Clinic
Patients with normal pregnancies being treated at first obstetric visit in clinic.
Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
Interventions
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Thromboelastometry testing
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
Eligibility Criteria
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Inclusion Criteria
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 ectopic pregnancies will also be excluded.
18 Years
65 Years
FEMALE
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Patrick Maher
Assistant Professor
Principal Investigators
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Patrick J Maher, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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GCO 18-0104
Identifier Type: -
Identifier Source: org_study_id
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