Pregnancy
Conditions
Keywords
sugammadex, ex-vivo placenta perfusion model, placental transfer, pregnancy, anesthesia
Brief summary
Preclinical research raised concern regarding the foetal effects of using sugammadex during pregnancy. However, to the best of our knowledge, the placental transfer of sugammadex has never been measured. As these data would be critical in assessing the foetal effects after maternal administration of sugammadex, it is warranted to measure the placental transfer of sugammadex. The aim of this project is to measure the placental transfer of sugammadex in the human placenta by using the ex vivo human placenta perfusion model.
Interventions
DRUGSugammadex
In an ex-vivo placenta perfusion study, placental transfer of sugammadex is measured.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* informed consent signed * (placenta of a) pregnant women with an uncomplicated pregnancy and delivery
Exclusion criteria
* chronic medication use during pregnancy * maternal diseases during pregnancy (including diabetes mellitus, hypertension, thyroid dysfunction), or any infection (chorioamnionitis and toxoplasmosis, other, rubella, cytomegalovirus, herpes infections, or a positive anti-HIV, anti-hepatitis B virus, or anti-hepatitis C virus serology)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foetal-maternal ratio of the drug | On the same day as collection of placenta | Drug concentrations of samples from the maternal and fetal compartment in the ex-vivo placenta perfusion model will be determined by high performance liquid chromatography and mass spectrometry. |
Countries
Belgium
Outcome results
None listed