Status:
RECRUITING
Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Normal Pregnancy
Eligibility:
FEMALE
18+ years
Brief 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 thro...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04400084
Start Date
June 5 2020
End Date
June 1 2030
Last Update
September 12 2025
Active Locations (1)
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1
CIC Port-Royal-Cochin
Paris, France, 75014