Understanding how drugs pass through the placenta during pregnancy
Official title: Placental Passage and Disposition of Drugs: A Physiology-based Approach
Run by Radboud University Medical Center · NCT02438631 · Data updated 2026-11-12
This study is trying to see how well different medications can cross the placenta during pregnancy to help doctors figure out the best dosages for pregnant women and understand how these drugs might affect their babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Status | Recruiting |
| Started | February 2015 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | September 10, 2022 |
| Trial ID | NCT02438631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women over 38 weeks gestation who can provide informed consent.
✕Probably not a fit
Patients with retained placenta, HIV infection, known hepatitis C infection, multiple pregnancies, congenital birth defects in the child, or those undergoing a Sectio EXIT procedure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to integrate outcomes from physiology-based pharmacokinetic (PBPK) models to better understand drug passage through the placenta in pregnant women. The researchers will validate these models using real-life maternal and fetal pharmacokinetic data, particularly from the PANNA network. The goal is to assist in designing appropriate drug dosing for pregnant women and to guide the development of new drugs by predicting their effects on the fetus.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective drug therapies for pregnant women and their babies.
How similar studies have gone: Other studies utilizing PBPK models have shown promise in understanding drug pharmacokinetics, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age \> 18 * Signed informed consent * \>38 weeks pregnant Exclusion Criteria: * Retained placenta * HIV infected * Known hepatitis C infection * Multiple pregnancy * Congenital birth defects child * Sectio EXIT procedure
Where it's running
-
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands Recruiting
Study contacts
- Principal investigator: J van Drongelen — Radboud University Medical Center
- Study coordinator: J van Drongelen
- Email: joris.vandrongelen@Radboudumc.nl
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.