Understanding how drugs pass through the placenta during pregnancy
Placental Passage and Disposition of Drugs: A Physiology-based Approach
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT02438631 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 38 weeks gestation who can provide informed consent.
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.
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 performed: Other studies utilizing PBPK models have shown promise in understanding drug pharmacokinetics, suggesting that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Nijmegen, Gelderland
- 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
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.