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Recruiting NCT02438631

Placental Passage and Disposition of Drugs: A Physiology-based Approach

— Observational Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network. PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).

Primary outcome measures

  • placental transfer [Time frame: at delivery]
  • histological profiling [Time frame: at delivery]
  • in vitro experiments [Time frame: at delivery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Radboud University Medical Centre — Nijmegen

Identifiers

NCT: NCT02438631 · PIANO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗