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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2017年1月26日

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Recurrent pregnancy losses. Women with >3 subsequent pregnancy losses or 3 pregnancy losses of which one was a 2. trimester loss.
发起方
Henriette Svarre Nielsen
入组人数
186
状态
进行中(未招募)
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2017年1月26日
结束日期
待定
最后更新
去年
研究类型
Interventional clinical trial of medicinal product
性别
Female

研究者

发起方
Henriette Svarre Nielsen

入排标准

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

结局指标

主要结局

未指定

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