PregnancyNCT06634355
Placental Transfer of Sugammadex in the Human Placental Perfusion Model
A study testing Sugammadex in people with Pregnancy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Mar 2025to Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- informed consent signed
- (placenta of a) pregnant women with an uncomplicated pregnancy and delivery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Sugammadex
- Keywords
- sugammadex, ex-vivo placenta perfusion model, placental transfer, pregnancy, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
In an ex-vivo placenta perfusion study, placental transfer of sugammadex is measured.
| Study group | Role | What they receive |
|---|---|---|
| ex-vivo placenta perfusion | Experimental | Measurement of placental transfer. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the same day as collection of placenta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start17 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristel Van Calsteren, MD, PhD, Principal investigator, University Hospital, GasthuisbergSarah Devroe, MD, Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634355
- Sponsor's protocol ID
- S54819(ML8732)
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No