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
适应症Recurrent pregnancy losses. Women with >3 subsequent pregnancy losses or 3 pregnancy losses of which one was a 2. trimester loss.MedDRA version: 19.1Level: LLTClassification code 10072314Term: Pregnancy lossSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
相关药物Plaquenil®
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。
研究者
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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