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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

Research output: Contribution to journalArticle

Standard

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

In: Seminars in Thrombosis and Hemostasis, 13.06.2017.

Research output: Contribution to journalArticle

Harvard

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. https://doi.org/10.1055/s-0037-1603359

APA

Schreiber, K., Breen, K., Cohen, H., Jacobsen, S., Middeldorp, S., Pavord, S., ... 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. https://doi.org/10.1055/s-0037-1603359

Vancouver

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 Jun 13. https://doi.org/10.1055/s-0037-1603359

Author

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

Bibtex Download

@article{768b7ef345f548cfb675ba41da092b7a,
title = "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",
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 = "Journal Article",
author = "Karen Schreiber and Karen Breen and Hannah Cohen and Soren Jacobsen and Saskia Middeldorp and Sue Pavord and Lesley Regan and Dario Roccatello and Robinson, {Susan E.} and Savino Sciascia and Seed, {Paul T.} and Linda Watkins and Hunt, {Beverley J.}",
year = "2017",
month = "6",
day = "13",
doi = "10.1055/s-0037-1603359",
language = "English",
journal = "Seminars in Thrombosis and Hemostasis",
issn = "0094-6176",
publisher = "Thieme Medical Publishers",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - HYdroxychloroquine to Improve Pregnancy Outcome in Women with AnTIphospholipid Antibodies (HYPATIA) Protocol

T2 - A Multinational Randomized Controlled Trial of Hydroxychloroquine versus Placebo in Addition to Standard Treatment in Pregnant Women with Antiphospholipid Syndrome or Antibodies

AU - Schreiber, Karen

AU - Breen, Karen

AU - Cohen, Hannah

AU - Jacobsen, Soren

AU - Middeldorp, Saskia

AU - Pavord, Sue

AU - Regan, Lesley

AU - Roccatello, Dario

AU - Robinson, Susan E.

AU - Sciascia, Savino

AU - Seed, Paul T.

AU - Watkins, Linda

AU - Hunt, Beverley J.

PY - 2017/6/13

Y1 - 2017/6/13

N2 - 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.

AB - 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.

KW - Journal Article

UR - http://www.scopus.com/inward/record.url?scp=85020704652&partnerID=8YFLogxK

U2 - 10.1055/s-0037-1603359

DO - 10.1055/s-0037-1603359

M3 - Article

C2 - 28609801

JO - Seminars in Thrombosis and Hemostasis

JF - Seminars in Thrombosis and Hemostasis

SN - 0094-6176

ER -

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