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

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

Department of Clinical Medicine

52 Citations (Scopus)

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.

Original language	English
Journal	Seminars in Thrombosis and Hemostasis
Volume	43
Issue number	6
Pages (from-to)	562-571
Number of pages	10
ISSN	0094-6176
DOIs	https://doi.org/10.1055/s-0037-1603359
Publication status	Published - 1 Sept 2017

Keywords

Journal Article

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Schreiber, K., Breen, K., Cohen, H., Jacobsen, S., Middeldorp, S., Pavord, S., Regan, L., Roccatello, D., Robinson, S. E., Sciascia, S., Seed, P. T., Watkins, L., & Hunt, B. J. (2017). 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. Seminars in Thrombosis and Hemostasis, 43(6), 562-571. https://doi.org/10.1055/s-0037-1603359

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. / Schreiber, Karen; Breen, Karen; Cohen, Hannah et al.

In: Seminars in Thrombosis and Hemostasis, Vol. 43, No. 6, 01.09.2017, p. 562-571.

Research output: Contribution to journal › Review › peer-review

Schreiber, K, Breen, K, Cohen, H, Jacobsen, S, Middeldorp, S, Pavord, S, Regan, L, Roccatello, D, Robinson, SE, Sciascia, S, Seed, PT, Watkins, L & Hunt, BJ 2017, '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', Seminars in Thrombosis and Hemostasis, vol. 43, no. 6, pp. 562-571. https://doi.org/10.1055/s-0037-1603359

Schreiber K, Breen K, Cohen H, Jacobsen S, Middeldorp S, Pavord S et al. 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. Seminars in Thrombosis and Hemostasis. 2017 Sept 1;43(6):562-571. doi: 10.1055/s-0037-1603359

Schreiber, Karen ; Breen, Karen ; Cohen, Hannah et al. / 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. In: Seminars in Thrombosis and Hemostasis. 2017 ; Vol. 43, No. 6. pp. 562-571.

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