Идёт набор NCT04207814

Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths

Без фазы С лечением Repeated Spontaneous Miscarriages Fetal Deaths in Utero

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: biological sample.
Кому может быть актуально: Состояния в реестре: Repeated Spontaneous Miscarriages, Fetal Deaths in Utero. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Биопрепарат biological sample
biological samples will be taken from the subjects included

Первичные конечные точки

Frequency difference of the determinant between the cases and the controls [Срок оценки: 34 years]

Вторичные конечные точки (1)

Occurrence of a new medical event [Срок оценки: 34 years]

Критерии участия

Критерии включения

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.