Placental Transfer of Sugammadex in the Human Placental Perfusion Model

Universitaire Ziekenhuizen KU Leuven

Status: Invitation-only

Conditions: Pregnancy

Treatments: Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT06634355

S54819(ML8732)

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

ex-vivo placenta perfusion

Experimental group

Description:

Measurement of placental transfer.

Treatment:

Drug: Sugammadex