跳至主要内容
临床试验/NCT04207814
NCT04207814招募中不适用

Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths (DEFI-2)

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Frequency difference of the determinant between the cases and the controls

研究概览

简要总结

The DEFI-1 study recruited 625 women witnesses and 299 of their spouses. With regard to case couples, 271 cases were recruited from the spontaneous repeated miscarriages (SRM) subgroup (≥3 spontaneous miscarriage (SM) from trimester 1 of pregnancy) and 93 from the unexplained fetal death in utero (FDIU) subgroup from trimesters 2 and 3 of pregnancy.

The main objective of the DEFI 2 study is to increase the number of case-pairs in these 2 particular subgroups to replicate the results of the genetic determinants highlighted from cases and controls with extreme phenotypes and obtain a sufficient number of women with FDIUs to identify specific determinants.

详细描述

The spontaneous repeated miscarriages (SRM) affect one to two fertile couples on 100, a fetal death in utero (FDIU) complicates the evolution of a pregnancy on 200. The SRM remain unexplained in 50% of the cases although a beam indirect arguments sometimes encourage to evoke a prothrombotic process and / or endothelial dysfunction, immunological disorders, an alteration of the ovarian reserve, and possibly the impact of genetic determinants. Regarding SRM, in the absence of a fetal, funicular cause or obvious preeclampsia, very diverse mechanisms are evoked depending on the placental histology (vasculoplacental, inflammatory, intervillitis, immunological, etc.). Thus, while these mechanisms remain for some to be demonstrated and are probably not unequivocal, clinicians are faced with a pressing request for therapeutic intervention on the part of patients. This is why, after having studied in DEFI-1 the 2 main constitutional thrombophilia in the 2 members of the couple, the procoagulant circulating microparticles and the generation of thrombin in the mother on the one hand, the modalities of inactivation of an X in the mother, on the other hand, a further investigation in subgroups of particular cases would be appropriate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • couples whose wife is over 18 and under 40 inclusive,
  • couples having undergone at least 3 unexplained SM in the first trimester or an FDIU in the trimesters 2 and 3 of pregnancy (excluding funicular and fetal causes and proven preeclampsia)
  • the man must be over 18 years old.
  • each member of the couple must consent to the investigation.
  • Subjects benefiting from a social security scheme.

排除标准

  • couples where the woman is under 18 or over 40,
  • couples whose man is under 18,
  • identified cause of SRM or FDIU
  • Inability to consent for one of the members of the couple,
  • refusal to participate for one of the members of the couple.
  • treatment with anticoagulants or anti-aggregating platelet for women.
  • Person under legal protection
  • Subjects not benefiting from a social security scheme
  • Refusal to participate

研究组 & 干预措施

Cases

Experimental

干预措施: biological sample (Biological)

结局指标

主要结局

Frequency difference of the determinant between the cases and the controls

时间窗: 34 years

The frequency difference of the determinant under study between the cases (studies DEFI-1 and DEFI-2) and the controls (study DEFI-1) will be measured.

次要结局

  • Occurrence of a new medical event(34 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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