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Clinical Trials in France / NCT04400084
Recruiting Observational

Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta

NCT04400084 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2020-06-05
Last updated
2025-09-12

Condition(s) studied

Normal Pregnancy

Investigational drug(s) / intervention(s)

Placenta perfusion

Placenta perfusion: Placenta perfusion in double closed circuit, during 3 hours

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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, Exclusion Criteria: * 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

Primary outcome measure(s)

  • Fetal transfer rate — At 180 minutes (end of the perfusion)
    Quantity of drug transferred into fetal compartment/ quantity of drug in the two compartments \*100

Trial sites (1)

FacilityCityRegionStatus
CIC Port-Royal-Cochin Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04400084 on ClinicalTrials.gov ↗ ← All trials in France