Longitudinal Study of the Clinical and Haematological Cau... | NCT00180817

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

NCT00180817

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Aug 8, 2022Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Antiphospholipid Syndrome

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1998Actual

Primary Completion Date

Aug 31, 2005Actual

Completion Date

Aug 31, 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2022

Last Update Posted Date

Aug 8, 2022Actual

Description Module

Brief Summary

This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Antiphospholipid syndrome History of recurrent miscarriages

Exclusion Criteria:

Previous thromboembolic disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Mary's Hospital		London		W2 1NY	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D016736	Antiphospholipid Syndrome

Ancestor Terms

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided