Placental Transfer of Sugammadex in the Human Placental P... | NCT06634355

Studies
Placental Transfer of Sugammadex in the Human Placental Perfusion Model

NCT06634355

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling by invitation

Last Update Posted

Jan 9, 2026Actual

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Sugammadex

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Oct 7, 2024

First Submission Date that Met QC Criteria

Oct 7, 2024

First Posted Date

Oct 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2026

Last Update Posted Date

Jan 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ex-vivo placenta perfusion	Experimental	Measurement of placental transfer.	Drug: Sugammadex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex	Drug	In an ex-vivo placenta perfusion study, placental transfer of sugammadex is measured.	ex-vivo placenta perfusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristel Van Calsteren, MD, PhD	University Hospital, Gasthuisberg	Principal Investigator
Sarah Devroe, MD, Phd	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven	Vlaams-Brabant	3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077122	Sugammadex

Ancestor Terms

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided