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

This study is currently recruiting participants.

Verified by Imperial College London, September 2005

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00180817

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

MedlinePlus related topics: Pregnancy Loss

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

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

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	EC3103
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00180817
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Antibodies
Autoimmune Diseases
Antiphospholipid syndrome
Abortion, Habitual
Antibodies, Antiphospholipid

Antiphospholipid Syndrome
Abortion, Spontaneous
Recurrence
Immunoglobulins

Additional relevant MeSH terms:

Pathologic Processes
Disease
Immunologic Factors
Immune System Diseases

Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009