Placental Transfer of Sugammadex in the Human Placental Perfusion Model

NCT06634355 | Enrolling By Invitation DMC

• 1 other identifier: S54819(ML8732)
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

sugammadex; ex-vivo placenta perfusion model; placental transfer; pregnancy; anesthesia

Outcome Measures

Primary Outcomes (1)

• Foetal-maternal ratio of the drug

  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.

  On the same day as collection of placenta

Study Arms (1)

ex-vivo placenta perfusion

EXPERIMENTAL

Measurement of placental transfer.

Drug: Sugammadex

Interventions

Sugammadex DRUG

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

ex-vivo placenta perfusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Kristel Van Calsteren, MD, PhD

  University Hospital, Gasthuisberg

  PRINCIPAL INVESTIGATOR

• Sarah Devroe, MD, Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)