Pregnancy Trimester, FirstTEMPURANCT03548701
Thromboelastometry Prediction Utility for Risk of Abortion
An observational study of Pregnancy Trimester, First and Abortion, Threatened, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pregnancy Trimester, First, Abortion, Threatened
- What is being tested?
- Thromboelastometry testing
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded.
- Patients with ectopic pregnancies will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Thromboelastometry testing
- Keywords
- Thromboelastometry, Vaginal Bleeding, Early Pregnancy
- Medical subject headings
- Abortion, Threatened, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thromboelastometry testingDiagnostic test
Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department | Patients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities. Receives: Diagnostic Test: Thromboelastometry testing | |
| Obstetric Clinic | Patients with normal pregnancies being treated at first obstetric visit in clinic. Receives: Diagnostic Test: Thromboelastometry testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: Day 1
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.
Measured: Day 1
Pregnancy Outcome
Assessment of pregnancy outcome. Variable is treated as categorical and coded as spontaneous abortion, preterm labor, or term labor.
Measured: Within 40 weeks of enrollment at completion of pregnancy
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.
Measured: Within 40 weeks of enrollment at completion of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start4 Jun 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Trimester, FirstStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Maher, Icahn School of Medicine at Mount Sinai
- Investigators
- Patrick J Maher, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548701
- Sponsor's protocol ID
- GCO 18-0104
- Acronym
- TEMPURA
- Status last verified
- May 2020
- First submitted
- 24 May 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15042008Harville 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.
PubMed 12923154Rai 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.
PubMed 14645169Bennett 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.
PubMed 24613698Armstrong 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.
PubMed 21835606
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastometry Prediction Utility for Risk of Abortion
- ClinicalTrials.gov ID
- NCT03548701
- Acronym / sponsor ID
- TEMPURA / GCO 18-0104
- Conditions
- Pregnancy Trimester, First, Abortion, Threatened
- Keywords
- Thromboelastometry, Vaginal Bleeding, Early Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Department | – | Diagnostic Test: Thromboelastometry testingPatients enrolled in the Emergency Department undergoing evaluation for threatened abortion abnormalities. |
| Obstetric Clinic | – | Diagnostic Test: Thromboelastometry testingPatients with normal pregnancies being treated at first obstetric visit in clinic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded.
- Patients with ectopic pregnancies will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thromboelastometry testingThromboelastometry testing - a form of testing in whole blood for coagulation abnormalities | Diagnostic test | Emergency Department, Obstetric Clinic |
Primary outcome
Maximum Clotting Firmness (MCF)
Time frame: Day 1
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.
4 secondary outcomes
Clot formation time (CFT)
Time frame: Day 1
Clotting Time (CT)
Time frame: Day 1
Pregnancy Outcome
Time frame: Within 40 weeks of enrollment at completion of pregnancy
Number of Pregnancy Complications
Time frame: Within 40 weeks of enrollment at completion of pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Background: PubMed 15042008Weiss 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.
- Background: PubMed 12923154Harville 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.
- Background: PubMed 14645169Rai 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.
- Background: PubMed 24613698Bennett 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.
- Background: PubMed 21835606Armstrong 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.
Related trials for Pregnancy Trimester, First
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
RecruitingObservational study
Research on Equity in Abortion Care by TeleHealth
Abortion in First Trimester, Abortion Early
RecruitingObservational study
First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
Neural Tube Defects (NTDs)
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Maher, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Trimester, First and Abortion, Threatened, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Clotting Firmness (MCF) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03548701, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.