Transplacental Transfer of Drugs Used in Pregnant Women
2 other identifiers
interventional
250
1 country
1
Brief Summary
The most important guideline for drug prescription concerning pregnant women is 'drugs should be given only if the maternal benefits outweigh the potential risk to the fetus'. However, poor data is available on maternal drug disposition and transfer through the placenta, so the evidence available for decision making in clinical practice is weak. An ex-vivo placenta perfusion model will be used to explore the mechanisms governing differences between fetal and maternal drug exposure. The expression of placental transporters and cytochrome P450 (CYP) enzymes will be investigated in primary placenta cell culture and placental biopsies from different gestational stages to learn how the placental drug transfer and disposition is regulated. The investigators choose to examine the transfer of paracetamol, erythromycin and azithromycin because these drugs are commonly used in human pregnancies and have different metabolic pathways.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Nov 2012
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 3, 2017
May 1, 2017
4.1 years
June 8, 2015
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transplacental transfer rate of drugs and their metabolites measured by comparing the concentrations in simultaneously collected samples from the maternal and fetal compartment in a human ex-vivo placenta perfusion model
the drug concentrations will be determined by high performance liquid chromatography and mass spectrometry
12 months for each drug
Study Arms (1)
ex-vivo placenta perfusion
EXPERIMENTALex vivo placenta perfusion study with exposure to paracetamol, erythromycin and azithromycin
Interventions
In an ex vivo placenta perfusion study, placental tissue is exposed to paracetamol
In an ex vivo placenta perfusion study, placental tissue is exposed to erythromycin
In an ex vivo placenta perfusion study, placental tissue is exposed to azithromycin
Eligibility Criteria
You may qualify if:
- informed consent has been signed
- (placenta of a) pregnant women with an uncomplicated pregnancy and delivery
You may not qualify if:
- use of medication during pregnancy
- hypertension, diabetes
- smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Gasthuisberg
Leuven, 3000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristel Van Calsteren, MD PhD
University Hospital Gasthuisberg Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr
Study Record Dates
First Submitted
June 8, 2015
First Posted
December 7, 2015
Study Start
November 1, 2012
Primary Completion
December 1, 2016
Study Completion
May 1, 2017
Last Updated
May 3, 2017
Record last verified: 2017-05