RecruitingNCT04400084

Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta

Ex Vivo Study of Drugs Transfer Across the Placenta


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

2,000 participants

Start Date

Jun 5, 2020

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria13

  • 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

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Interventions

OTHERPlacenta perfusion

Placenta perfusion in double closed circuit, during 3 hours


Locations(1)

CIC Port-Royal-Cochin

Paris, France

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NCT04400084