Semin Thromb Hemost 2017; 43(06): 562-571
DOI: 10.1055/s-0037-1603359
Review Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

HYdroxychloroquine to Improve Pregnancy Outcome in Women with AnTIphospholipid Antibodies (HYPATIA) Protocol: A Multinational Randomized Controlled Trial of Hydroxychloroquine versus Placebo in Addition to Standard Treatment in Pregnant Women with Antiphospholipid Syndrome or Antibodies

Karen Schreiber
1  Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
2  Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark
,
Karen Breen
1  Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
,
Hannah Cohen
3  Haemostasis Research Unit, Department of Haematology, University College London, London, United Kingdom
,
Soren Jacobsen
2  Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark
,
Saskia Middeldorp
4  Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
,
Sue Pavord
5  Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford United Kingdom
,
Lesley Regan
6  Obstetrics and Gynaecology Department, St Mary's Hospital, Imperial College, Praed Street, London, United Kingdom
,
Dario Roccatello
7  Department of Clinical and Biological Sciences, Center of Research of Immunopathology and Rare Diseases- Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Hospital and University of Turin, Torino, Italy
,
Susan E. Robinson
1  Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
,
Savino Sciascia
7  Department of Clinical and Biological Sciences, Center of Research of Immunopathology and Rare Diseases- Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Hospital and University of Turin, Torino, Italy
,
Paul T. Seed
8  King's Health Partners, King's College London, London, United Kingdom
,
Linda Watkins
9  Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, United Kingdom
,
Beverley J. Hunt
1  Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
› Author Affiliations
Further Information

Publication History

Publication Date:
13 June 2017 (online)

Abstract

Women with antiphospholipid antibodies (aPL) are at risk of adverse pregnancy outcomes, including recurrent first-trimester pregnancy loss and late pregnancy complications such as preeclampsia, HELLP (hemolysis, elevated liver enzyme levels, and low platelet levels) syndrome, premature delivery, intrauterine growth restriction, placental abruption, and intrauterine death. Current standard care in obstetric antiphospholipid syndrome includes aspirin and heparin and has resulted in live-birth rates of approximately 70%. However, 30% continue to have pregnancy complications. Hydroxychloroquine (HCQ) is suggested as a new treatment approach, but no randomized controlled trials (RCTs) have assessed its efficacy. This study aims to assess pregnancy outcome in women with aPL treated with HCQ versus placebo in addition to standard treatment. The HYdroxychloroquine to improve Pregnancy outcome in women with AnTIphospholipid Antibodies (HYPATIA) study is a phase IV multicenter RCT, in which pregnant women with persistent aPL will receive either HCQ or placebo in addition to their usual medication. The primary endpoint is a composite of aPL-related adverse pregnancy outcomes: one or more pregnancy loss(es) (either < 10 or > 10 weeks of gestation) and premature birth before 34 weeks due to any of the following preeclampsia, eclampsia, or recognized features of placental insufficiency. The HYPATIA study is expected to provide evidence on the effect of HCQ in pregnant women with persistent aPL.

Funding

The HYPATIA study is funded by the NIHR Research for Patient Benefit (RfBP).


Notes

B.J.H. and K.S. have designed the trial. All authors and collaborators have reviewed and edited the draft version of the article and approved the final version. All authors have approved the final article submitted. Trial registration: EUDRACT: 2016–002256–25.