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Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study

Identifieur interne : 000016 ( France/Analysis ); précédent : 000015; suivant : 000017

Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study

Auteurs : Elisabeth Pasquier [France] ; Luc De Saint-Martin [France] ; Gisèle Marhic [France] ; Céline Chauleur [France] ; Caroline Bohec [France] ; Florence Bretelle [France] ; Véronique Lejeune-Saada [France] ; Jacob Hannigsberg [France] ; Geneviève Plu-Bureau [France] ; Virginie Cogulet [France] ; Philippe Merviel [France] ; Dominique Mottier [France]

Source :

RBID : Hal:hal-02082511

Abstract

Recurrent miscarriage (RM), defined by three or more consecutive losses during the first trimester of pregnancy, affects 1%–2% of fertile couples. Standard investigations fail to reveal any apparent cause in ~50% of couples. However, on the basis of animal models and clinical studies, several hypotheses have been put forward concerning underlying mechanisms of RM: altered ovarian reserve, progesterone defect, thrombotic and/or endothelial dysfunction and immunological disturbances. Nonetheless, no study has yet reached conclusive beneficial clinical evidence for a potential treatment in unexplained RM. Hydroxychloroquine (HCQ) is a molecule with extensive safety data during pregnancy. The pharmacological properties of HCQ (eg, antithrombotic, vascular protective, immunomodulatory, improved glucose tolerance, lipidlowering and anti-infectious) could be effective against some mechanisms of unexplained RM. Furthermore, eventhough clinical benefit of HCQ is suggested in prevention of thrombotic and late obstetric events in antiphospholipid (APL) syndrome, there are no data suggesting the benefit of HCQ in RM in the presence of APL antibodies.


Url:
DOI: 10.1136/bmjopen-2018-025649


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Hal:hal-02082511

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<idno type="DOI">10.1136/bmjopen-2018-025649</idno>
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<title level="j">BMJ Open</title>
<idno type="ISSN">2044-6055</idno>
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<front>
<div type="abstract" xml:lang="en">
<p>Recurrent miscarriage (RM), defined by three or more consecutive losses during the first trimester of pregnancy, affects 1%–2% of fertile couples. Standard investigations fail to reveal any apparent cause in ~50% of couples. However, on the basis of animal models and clinical studies, several hypotheses have been put forward concerning underlying mechanisms of RM: altered ovarian reserve, progesterone defect, thrombotic and/or endothelial dysfunction and immunological disturbances. Nonetheless, no study has yet reached conclusive beneficial clinical evidence for a potential treatment in unexplained RM. Hydroxychloroquine (HCQ) is a molecule with extensive safety data during pregnancy. The pharmacological properties of HCQ (eg, antithrombotic, vascular protective, immunomodulatory, improved glucose tolerance, lipidlowering and anti-infectious) could be effective against some mechanisms of unexplained RM. Furthermore, eventhough clinical benefit of HCQ is suggested in prevention of thrombotic and late obstetric events in antiphospholipid (APL) syndrome, there are no data suggesting the benefit of HCQ in RM in the presence of APL antibodies.</p>
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<name sortKey="Plu Bureau, Genevieve" sort="Plu Bureau, Genevieve" uniqKey="Plu Bureau G" first="Geneviève" last="Plu-Bureau">Geneviève Plu-Bureau</name>
</country>
</tree>
</affiliations>
</record>

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