Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment2000 (estimated)
SponsorRadboud University Medical Center
Academic / other
Locations1 site (Nijmegen, Gelderland)
StatusRecruiting
StartedFebruary 2015
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedSeptember 10, 2022
Trial IDNCT02438631 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.