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Coagulation Parameters During Pregnancy in Amniotic Fluid

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ClinicalTrials.gov Identifier: NCT00458666
Recruitment Status : Unknown
Verified March 2007 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : April 11, 2007
Last Update Posted : April 11, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Condition or disease
Pregnancy

Detailed Description:
Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Study Design

Study Type : Observational
Estimated Enrollment : 170 participants
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Coagulation Parameters During Pregnancy in Amniotic Fluid
Study Start Date : June 2006
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing amniocentesis during 15-35 weeks of gestation.

Exclusion Criteria:

  • A history of venous thromboembolism
  • Systemic disease i.e.; diabetes, hypertension, hypo or hyper-thyroidism,
  • Anticoagulant treatment
  • Abnormal embryo
Contacts and Locations

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): NCT00458666


Contacts
Contact: Galit Sarig, Ph.D +972-50-2061462 g_sarig@rambam.health.gov.il

Locations
Israel
Dept of Obstetrics and Gynecology, Rambam-Health Care Campus Recruiting
Haifa, Israel
Contact: Arie Drugan, M.D    +972-50-206-2006    a_drugan@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Benjamin Brenner, M.D Rambam Health Care Campus
Study Chair: Arie Drugan, M.D Rambam Health Care Campus
More Information

ClinicalTrials.gov Identifier: NCT00458666     History of Changes
Other Study ID Numbers: CoagulationAmnioticFluid_CTIL
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: March 2007

Keywords provided by Rambam Health Care Campus:
Amniotic fluid
D-dimer
coagulation
factor X activation