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MULTICENTRE STUDIES

LONG TERM HEALTH IMPLICATIONS OF PRIMARY ANTIPHOSPHOLIPID ANTIBODY SYNDROME IN WOMEN PRESENTING WITH RECURRENT MISCARRIAGE – A PROSPECTIVE LONGITUDINAL STUDY


 

COORDINATORS

 

Preeti Jindal MD, May Backos MD, Winnie Lo RCN, Raj Rai MD, Lesley Regan MD (sponsor).

Clinical Obstetrics and Gynaecology, St Mary’s Hospital, Imperial College London, London W2 1NY, United Kingdom

 

 

PROJECT

 

Background:  Primary antiphospholipid syndrome (PAPS) is diagnosed in 15 - 20% of women with recurrent miscarriage (RM) - > 3 consecutive pregnancy losses.  In addition to the obstetric implications, PAPS has also been associated with the development of vascular, dermatological, neurological and haematological manifestations in later life.  However, the advice that should be offered to RM women who are identified as having PAPS, regarding their risks of future morbidity are unclear. There are few published reports on the long term health implications of PAPS and the majority are retrospective or cross sectional studies recruiting women with recurrent thrombotic events. This study was designed to overcome the limitations of available data by recruiting women with RM diagnosed with PAPS to a prospective, longitudinal follow up programme to assess their long term health risks.

Objectives:  To follow the natural history of PAPS in women whose first presenting medical symptom is Recurrent Miscarriage. To determine their frequency of symptomatic venous thrombotic events (VTE), cerebrovascular accidents (CVA) and other antiphospholipid related clinical manifestations including the development of systemic lupus erythematosus (SLE). 

Methods:  This prospective longitudinal study has been ongoing since December 1997 based in the Recurrent Miscarriage Clinic at St. Mary’s Hospital, London.  To date 500 women with history of three or more miscarriages, persistently positive tests for antiphospholipid antibodies and no history of VTE, CVA or SLE have been invited to complete an initial medical health questionnaire and have been registered for long term follow up. Of these recruits, 201 women have now completed 8 years of follow up and their results are presented here. 

Results: The median age of these 201 women at the time of initial diagnosis of PAPS was 34 years (range 22 – 43 ) and their 8 year follow up period included a total of 947 patient years.  The incidence of VTE was 4.2/1000 patient-years, the incidence of CVA was 2.1/1000 patient years and the incidence of SLE was 1.5/1000 patient-years.  By contrast , the incidence of VTE in an unselected European population is generally quoted as 0.54/1000 patient-years and for SLE the incidence is 1/1000 patient-years. 

Conclusions: The initial results from this longitudinal study suggest that RM women diagnosed with PAPS are at increased risk of suffering a VTE, CVA or developing SLE in later life. They should be counselled accordingly and given advice regarding life style measures aimed at minimising their risks, such as avoiding smoking, obesity, dehydration and prolonged immobility. Whether they should all receive low dose aspririn thromboprophylaxis or be denied future hormonal contraception and post menopausal hormone replacement is unclear at present. All the VTE’s in this study cohort occurred subsequent to a further prothrombotic insult such as long haul travel or major pelvic surgery, suggesting that adequate thromboprophylaxis should be advised in these circumstances.

For additional information and applications, please e-mail: l.regan@imperial.ac.uk


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Last updated: 17 November 2005