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; Karen Breen; Hannah Cohen; Soren Jacobsen; Saskia Middeldorp; Sue Pavord; Lesley Regan; Dario Roccatello; Susan E. Robinson; Savino Sciascia; Paul T. Seed; Linda Watkins; Beverley J. Hunt

doi:10.1055/s-0037-1603359

Seminars in Thrombosis and Hemostasis, Table of Contents

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

Authors

Karen Schreiber

¹Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom

²Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark
Karen Breen

¹Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
Hannah Cohen

³Haemostasis Research Unit, Department of Haematology, University College London, London, United Kingdom
Soren Jacobsen

²Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark
Saskia Middeldorp

⁴Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Sue Pavord

⁵Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford United Kingdom
Lesley Regan

⁶Obstetrics and Gynaecology Department, St Mary's Hospital, Imperial College, Praed Street, London, United Kingdom
Dario Roccatello

⁷Department 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

¹Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
Savino Sciascia

⁷Department 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

⁸King's Health Partners, King's College London, London, United Kingdom
Linda Watkins

⁹Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, United Kingdom
Beverley J. Hunt

¹Thrombosis and Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom

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.

Keywords

antiphospholipid antibodies - antiphospholipid syndrome - obstetric antiphospholipid syndrome - pregnancy - hydroxychloroquine

Full Text

References

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