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Набор скоро начнётся NCT05188066

Study of Pregnancy Pathologies Associated With Placental Abnormalities

— Наблюдательное Pre-eclampsia Pre-Term Fetal Growth Retardation

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: Histology.
Кому может быть актуально
Состояния в реестре: Pre-eclampsia, Pre-Term, Fetal Growth Retardation. Базовые параметры: 18 лет — 52 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them. The investigators need to collect samples, especially placental samples, following abortions and term and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for the understanding of the histological changes that occur in normal placentas collected at term of pregnancy. The latter will, in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of pre-eclampsia. This study will allow investigators to advance their understanding of the pathophysiological mechanisms of the placenta. The investigators are internationally recognized for their research on these pathologies.

Подробное описание

Pregnancy pathologies can occur from implantation until childbirth. Clinical and scientific investigators are interested in the study of the mechanisms of development of these pathologies and aim to develop therapies to treat them.

The investigators need to collect samples, especially placental samples, following abortions, term, and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for understanding the histological changes that occur in normal placentas collected at term of pregnancy. The latter, will in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of preeclampsia. This study will allow investigators to advance the understanding of the pathophysiological mechanisms of the placenta.

The investigators are internationally recognized for its research on these thematic.

Вмешательства

  • Диагностический тест Histology
    Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses

Первичные конечные точки

  • To better characterize pregnancy pathologies from implantation to childbirth [Срок оценки: Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours]
Вторичные конечные точки (1)
  • Link between the frequencies of histological aberrations and worsening of the pathology [Срок оценки: Assessement of the link between the frequencies of histological aberrations and worsening of the pathology will be assessed on the final cohort; This will take up to 3 hours for each aberration.]

Критерии участия

Критерии включения

Adult women

  • Admitted to the CHUGA for a birth or an abortion.
  • Pregnant women consenting to the collection of their fetal placenta membranes, during premature deliveries or at term of pregnancy OR Women performing an abortion consenting to the collection of their abortion products.
  • Having signed a consent
  • Affiliated with social security

Критерии исключения

  • Placental sample or abortion product unavailable (not collected or necessary for treatment).
  • Patient with known positive HIV or Hepatitis B or Hepatitis C serology or at risk according to the infectious safety criteria applied by the EFS.
  • hemoglobin <7d / dL or hemoglobin <10g / dL if she suffers from a cardio-respiratory pathology).
  • Patient protected by law (minor, hospitalized under duress, subject to a legal protection measure by guardianship or curatorship, deprived of liberty by judicial or administrative decision)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05188066 · 38RC20.115

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗