NCT00458666

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
Last Updated

April 11, 2007

Status Verified

March 1, 2007

First QC Date

April 10, 2007

Last Update Submit

April 10, 2007

Conditions

Pregnancy

Keywords

Amniotic fluidD-dimercoagulationfactor X activation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Obstetrics and Gynecology, Rambam-Health Care Campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Benjamin Brenner, M.D

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • Arie Drugan, M.D

    Rambam Health Care Campus

    STUDY CHAIR

Central Study Contacts

Galit Sarig, Ph.D

CONTACT

+972-50-2061462g_sarig@rambam.health.gov.il

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

June 1, 2006

Last Updated

April 11, 2007

Record last verified: 2007-03

Locations

IL(1)