Placental Transfer of Sugammadex in the Human Placental Perfusion Model

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sugammadex

Drug

In an ex-vivo placenta perfusion study, placental transfer of sugammadex is measured.

Primary outcomes

Foetal-maternal ratio of the drug

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 9, 2024
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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