Health TrialsbyHealthPanel

Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta

ConditionNormal Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

diabetes-like vascular disease,

arterial hypertension,

known prothrombotic pathology, history of venous thrombosis or pulmonary embolism,

maternal serology HIV+, BHV+, CHV+ and syphilis,

Trial population

Pregnant women who give birth in the Port-Royal maternity (Paris)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Placenta perfusion

    Other intervention

    Placenta perfusion in double closed circuit, during 3 hours

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Pregnant mothers1 intervention

Trial outcomes

Primary outcomes

1

Fetal transfer rate

Quantity of drug transferred into fetal compartment/ quantity of drug in the two compartments \*100

Time frame
At 180 minutes (end of the perfusion)

Secondary outcomes

1

Ratio of concentrations

Fetal concentration / maternal concentration \*100

Time frame
At 180 minutes (end of the perfusion)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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