Studying how drugs transfer through the placenta
Ex Vivo Study of Drugs Transfer Across the Placenta
This study is testing how different drugs move through the placenta to see how they might affect pregnant women and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04400084 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the transfer of drugs across the placenta using human cotyledon perfusion after delivery. Pregnant women are often excluded from clinical trials, leading to a lack of data on drug safety and efficacy during pregnancy. By perfusing the maternal and fetal sides of the placenta with a drug and a control molecule, researchers will analyze the concentrations of these substances to understand the mechanisms and quantities of drug transfer. The study will also explore factors that may influence drug transfer, such as genetics and protein expression.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old, from the 24th week of amenorrhea, who have provided informed consent.
Not a fit: Patients with pre-existing maternal pathologies or pregnancy complications, such as diabetes or pre-eclampsia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide crucial insights into the safety and efficacy of medications used during pregnancy, ultimately improving maternal and fetal health outcomes.
How similar studies have performed: While studies on drug transfer across the placenta exist, this specific approach using cotyledon perfusion is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- CIC Port-Royal-Cochin — Paris, France (Recruiting)
Study contacts
- Study coordinator: Jean-Marc TRELUYER, Pr
- Email: jean-marc.treluyer@parisdescartes.fr
- Phone: 00 33 1 58 41 28 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.