NCT04400084 Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta
| NCT ID | NCT04400084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Normal Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2020-06-05 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2020-06-05 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04400084 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Normal Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04400084 currently recruiting?
Yes, NCT04400084 is actively recruiting participants. Contact the research team at jean-marc.treluyer@parisdescartes.fr for enrollment information.
Where is the NCT04400084 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04400084 clinical trial?
NCT04400084 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 2,000 participants.