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Placental Transfer of Sugammadex in the Human Placental Perfusion Model

NCT06634355 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-01-09

No results posted yet for this study

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

Interventions

DRUG

Sugammadex

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Kristel Van Calsteren, MD, PhD · University Hospital, Gasthuisberg

  • Sarah Devroe, MD, Phd · UZ Leuven

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634355 on ClinicalTrials.gov