- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00180817
Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies.
August 4, 2022 updated by: Imperial College London
Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies in Women Presenting as Recurrent Miscarriages.
This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, W2 1NY
- St. Mary's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Antiphospholipid syndrome History of recurrent miscarriages
Exclusion Criteria:
Previous thromboembolic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Other
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raj Rai, MRCOG, Imperial College London
- Principal Investigator: Preeti Jindal, MRCOG, St. Mary's NHS Trust, London
- Principal Investigator: Winnie Lo, St. Mary's NHS Trust, London
- Principal Investigator: Lesley Regan, Imperial College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 1998
Primary Completion (Actual)
August 31, 2005
Study Completion (Actual)
August 31, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 4, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC3103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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