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Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies.

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 September 2005 by Imperial College London.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180817
First Posted: September 16, 2005
Last Update Posted: September 16, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Imperial College London
  Purpose
This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.

Condition
Antiphospholipid Syndrome

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies in Women Presenting as Recurrent Miscarriages.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Estimated Enrollment: 250
Study Start Date: September 1998
Estimated Study Completion Date: August 2005
Detailed Description:
The association between APA and thrombosis is well documented. Both LA and ACA are often detected in individuals with SLE but there is no prospective data on the risk of thrombosis in women who present with recurrent miscarriages in association with APA. This study should significantly advance medical knowledge of the natural history of primary antiphospholipid syndrome (PAPS) which is essential to enable optimal management of relatively young women who may be at risk of complications, some of which are potentially life threatening.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Antiphospholipid syndrome History of recurrent miscarriages

Exclusion Criteria:

Previous thromboembolic disease

  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): NCT00180817


Contacts
Contact: Lesley Regan, FRCOG 02078861050 l.regan@imperial.ac.uk

Locations
United Kingdom
St. Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Lesley Regan, FRCOG    02078861050    l.regan@imperial.ac.uk   
Principal Investigator: Lesley Regan, FRCOG         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Lesley Regan Imperial College London
Principal Investigator: Raj Rai, MRCOG Imperial College London
Principal Investigator: Winnie Lo St. Mary's NHS Trust, London
Principal Investigator: Preeti Jindal, MRCOG St. Mary's NHS Trust, London
  More Information

ClinicalTrials.gov Identifier: NCT00180817     History of Changes
Other Study ID Numbers: EC3103
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 16, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Antibodies
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs