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Идёт набор NCT04400084

Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta

— Наблюдательное Normal Pregnancy

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: Placenta perfusion.
Кому может быть актуально
Состояния в реестре: Normal Pregnancy. Базовые параметры: от 18 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
Франция
Следующий шаг
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Официальное название

Ex Vivo Study of Drugs Transfer Across the Placenta

Обзор

Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.

Подробное описание

For ethical reasons, pregnant woman are not included in clinical trials so that data regarding safety and efficacy of many drugs are scarce. It is known that xenobiotics across the placental barrier but studies regarding quantity and mechanisms of this transfer remain insuffisant. Among the different methodologies to evaluate drug transfer, perfusion of human cotyledon is one of the most relevant ones. The two sides of the cotyledon, fetal and maternal ones, are perfused within the hour after delivery with EARLE medium in a double closed circuit. The studied drug (it can be any drug given to pregnant mothers) and antipyrine (the control molecule) are added at the beginning of the three hours perfusion realized at 37°C, with maternal flow rate of 12ml/min and fetal one of 6ml/min. Samples are collected along the perfusion and the drugs dosage will be done in the pharmacology department of Cochin Hospital. Tissues of the cotyledon will be also collected to study the proteins, and ARNs expressed. The drug concentrations will be analyzed by calculating fetal to maternal concentrations ratios and a fetal transfer rate (fetal drug quantity on total drug quantity at the end of the perfusion). Then modelling on Monolix software will be done to estimate the transfer constants across the two compartments. Modelling will allow to estimate the interindividual variability and to test covariables like sex, gestation duration, genetics, or protein expression. Proteins will be studied by an appropriated method (western blot, or proteomic analysis). The genetics study will consist in candidate gene approach. Polymorphisms will be chosen in genes coding for transporters or enzymes or their regulators.

Вмешательства

  • Другое Placenta perfusion
    Placenta perfusion in double closed circuit, during 3 hours

Первичные конечные точки

  • Fetal transfer rate [Срок оценки: At 180 minutes (end of the perfusion)]
Вторичные конечные точки (1)
  • Ratio of concentrations [Срок оценки: At 180 minutes (end of the perfusion)]

Критерии участия

Критерии включения

  • pregnant women older than 18 years,
  • patient with social security or health insurance,
  • from the 24th week of amenorrhea,
  • patient who has given her consent,

Критерии исключения

  • Maternal pathologies pre-existing pregnancy :
  • diabetes-like vascular disease,
  • arterial hypertension,
  • known prothrombotic pathology, history of venous thrombosis or pulmonary embolism,
  • maternal serology HIV+, BHV+, CHV+ and syphilis,
  • Pregnancy and fetal pathologies :
  • pre-eclampsia,
  • delayed growth in utero (can affect placental circulation),
  • gestational diabetes without insulin,
  • fetal malformation,
  • known genetic pathology,
  • Patient under tutorship or curatorship, or not speaking french,
  • Patient who has not given her consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • CIC Port-Royal-Cochin — Paris

Публикации

  • Schneider H, Panigel M, Dancis J. Transfer across the perfused human placenta of antipyrine, sodium and leucine. Am J Obstet Gynecol. 1972 Nov 15;114(6):822-8. doi: 10.1016/0002-9378(72)90909-x. No abstract available. PMID 4676572
  • Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011 Jul;90(1):67-76. doi: 10.1038/clpt.2011.66. Epub 2011 May 11. PMID 21562489
  • Preta LH, Bouazza N, Foissac F, Froelicher L, Urien S, Dauvilliers A, Dinnall A, Buth V, Benaboud S, Treluyer JM, Lui G. Comparison of human transplacental transfer of escitalopram, sertraline and paroxetine: an ex vivo cotyledon perfusion study. Placenta. 2025 Aug;168:150-158. doi: 10.1016/j.placenta.2025.06.015. Epub 2025 Jun 24. PMID 40580785

Идентификаторы

NCT: NCT04400084 · APHP190817

Первоисточники (государственные реестры)

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