NCT02438631|Recruiting
Placental Passage and Disposition of Drugs: A Physiology-based Approach
PIANO
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PIANO
Sponsor study identifier
observational
2,000
1 country
1
Study Start
February 2015
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Actual (reported)May 6, 2015
Actual (reported)May 8, 2015
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
placental transfer
1.) An ex-vivo placenta perfusion model will be used to estimate placental passage of drugs
at delivery
histological profiling
Histological and protein profiling experiments will be conducted to investigate factors that may influence the placental passage and disposition of drugs (e.g. the abundance, localization and inter-individual variation of expression of enzymes and transporters).
at delivery
in vitro experiments
Furthermore, in vitro experiments will be conducted to estimate the pharmacodynamic effects of drugs on the placental barrier function itself (e.g. whether exposure to drugs can induce/reduce the expression of enzymes and transporters, as has been reported for several organs, such as the liver, intestine and kidney).
at delivery
Pregnant women
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Placental tissue is retained, limited sample. DNA will not be analysed.
J van Drongelen
Radboud University Medical Center
First Submitted
May 6, 2015
First Posted
May 8, 2015
Study Start
February 2015
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?
Contact the study team to confirm eligibility.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 10, 2022
Record last verified: 2022-09
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