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Coagulation Parameters During Pregnancy in Amniotic Fluid

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00458666
First received: April 10, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose
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
Pregnancy

Study Type: Observational
Study Design: Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Coagulation Parameters During Pregnancy in Amniotic Fluid

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 170
Study Start Date: June 2006
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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 10, 2007
Last Updated: April 10, 2007

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

ClinicalTrials.gov processed this record on September 19, 2017