Thrombin Generation and Gestational Outcome | NCT02139670

Studies
Thrombin Generation and Gestational Outcome

NCT02139670

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Mar 1, 2018Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Thrombophilia

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Sep 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 26, 2013

First Submission Date that Met QC Criteria

May 13, 2014

First Posted Date

May 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2018

Last Update Posted Date

Mar 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elias mazen, Director of Internal medicine, HaEmek Medical Center, IsraelPrincipal Investigator

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

29Actual

Label	Type	Description	Intervention Names
pregnant womens

Measure	Description	Time Frame
pregnancy outcome		2 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

pregnant women with recurrent miscarriages undergoing investigation for Thrombophilia .

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mazen elias, prof	HaEmek Medical Center, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haemek medical center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D019851	Thrombophilia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

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