Placental Transfer of Sugammadex in the Human Placental Perfusion Model
- Registration Number
- NCT06634355
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 16
- informed consent signed
- (placenta of a) pregnant women with an uncomplicated pregnancy and delivery
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ex-vivo placenta perfusion Sugammadex Measurement of placental transfer.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium