Clinical trial NCT03548701: Thromboelastometry Prediction Utility for Risk of Abortion
Official title: Thromboelastometry Prediction Utility for Risk of Abortion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Trimester, First
Abortion, Threatened
Keywords: Thromboelastometry
Vaginal Bleeding
Early Pregnancy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Maximum Clotting Firmness (MCF)
timeFrame: Day 1
Secondary outcomes:
measure: Clot formation time (CFT)
timeFrame: Day 1
measure: Clotting Time (CT)
timeFrame: Day 1
measure: Pregnancy Outcome
timeFrame: Within 40 weeks of enrollment at completion of pregnancy
measure: Number of Pregnancy Complications
timeFrame: Within 40 weeks of enrollment at completion of pregnancy
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Patrick J Maher, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ajog.2003.09.023.
citation: 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.
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. doi: 10.1093/humrep/deg494.
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.
citation: 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.