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临床试验/EUCTR2016-004981-24-DK
EUCTR2016-004981-24-DK进行中(未招募)1 期

Hydroxychloroquin (Plaquenil) treatment of recurrent pregnancy loss – a randomized, double blinded, placebo controlled study - Hydroxychloroquin treatment of abortus habitualis

Henriette Svarre Nielsen0 个研究点目标入组 186 人开始时间: 2017年1月26日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
186

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • >3 recurrent subsequent spontaneous pregnancy losses or 3 recurrent subsequent spontaneous pregnancy losses of which one is a second trimester loss.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 186
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1) Age below 18 or above 40 at the time of achieved pregnancy
  • 2) Significant uterine abnormalities diagnosed by hysterosalpingography/hysteroscopy/hydrosonography.
  • 3) Significant chromosome abnormalia (especially tranlocations) in the couple
  • 4) Menstruation cycle < 23 days or > 35 days
  • 5) Lupusanticoagulans or IgG anticardiolipinantibody concentration =40 GPL kU/l or plasma homocystein =25 mikrogr./l after recurrent measurements with 8 weeks intervals before pregnancy
  • 6) Positive test for HIV or tests suggestive på hepatitis B or C carrier state.
  • 7) Psoriasis, retinopathy and adverse hearing loss (contra indications for Plaquenil)
  • 8) Chronical diseases requiring anti inflammatory medicine or medicine potentially harmfull to pregnancy: corticosteroids, acetylsalicyle acid, indometacin, simvastatin, imurel ect.. Periodic paracetamol use is allowed.
  • 9) >1 previous live birth
  • 10) Previous participation in the study

研究者

发起方
Henriette Svarre Nielsen

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