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
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