Transplacental Transfer of Drugs Used in Pregnant Women

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Gasthuisberg
• Treatments: Acetaminophen; Azithromycin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Criteria

Inclusion Criteria:

• informed consent has been signed

• (placenta of a) pregnant women with an uncomplicated pregnancy and delivery

Exclusion Criteria:

• use of medication during pregnancy

• hypertension, diabetes

• smoking