Thrombin Generation and Gestational Outcome
1 other identifier
observational
29
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 1, 2018
February 1, 2018
2.9 years
August 26, 2013
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
pregnancy outcome
2 years
Study Arms (1)
pregnant womens
Eligibility Criteria
pregnant women with recurrent miscarriages undergoing investigation for Thrombophilia .
You may qualify if:
- age \> 18
- signed inform consent
- first trimester
- two early miscarriages(before week 10) or one later abortions (after week 10)
You may not qualify if:
- Chronic treatment with aspirin or other anticoagulants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haemek medical center
Afula, 18101, Israel
Biospecimen
4 cc of serum will be retain until all blood samples will be collected
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mazen elias, prof
HaEmek Medical Center, Israel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 9 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Internal medicine
Study Record Dates
First Submitted
August 26, 2013
First Posted
May 15, 2014
Study Start
October 1, 2013
Primary Completion
September 1, 2016
Study Completion
December 1, 2017
Last Updated
March 1, 2018
Record last verified: 2018-02