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Transplacental Transfer of Drugs Used in Pregnant Women

NCT02622802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-05-03

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DRUG

paracetamol

In an ex vivo placenta perfusion study, placental tissue is exposed to paracetamol

DRUG

Erythromycin

In an ex vivo placenta perfusion study, placental tissue is exposed to erythromycin

DRUG

Azithromycin

In an ex vivo placenta perfusion study, placental tissue is exposed to azithromycin

Sponsors & Collaborators

  • University Hospital, Gasthuisberg

    lead OTHER

Principal Investigators

  • Kristel Van Calsteren, MD PhD · University Hospital Gasthuisberg Leuven

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622802 on ClinicalTrials.gov