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Thrombin Generation and Gestational Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139670
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel

Brief Summary:
In total 120 pregnant women's with history of recurrent miscarriages, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy outcome and thrombin measurements will be determined

Condition or disease
Thrombophilia

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Study Type : Observational [Patient Registry]
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Thrombin Generation and Gestational Outcome in Women With Recurrent Pregnancy Loss
Study Start Date : October 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

Group/Cohort
pregnant womens



Primary Outcome Measures :
  1. pregnancy outcome [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
4 cc of serum will be retain until all blood samples will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women with recurrent miscarriages undergoing investigation for Thrombophilia .
Criteria

Inclusion Criteria:

  • age > 18
  • signed inform consent
  • first trimester
  • two early miscarriages(before week 10) or one later abortions (after week 10)

Exclusion Criteria:

  • Chronic treatment with aspirin or other anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139670


Locations
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Israel
Haemek medical center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: mazen elias, prof HaEmek Medical Center, Israel
Additional Information:

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Responsible Party: Elias mazen, Director of Internal medicine, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02139670    
Other Study ID Numbers: thrombin generation- pregnancy
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Thrombophilia
Hematologic Diseases