Placental Transfer of Sugammadex in the Human Placental Perfusion Model
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Foetal-maternal ratio of the drug
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed consent signed
- •(placenta of a) pregnant women with an uncomplicated pregnancy and delivery
排除标准
- •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)
研究组 & 干预措施
ex-vivo placenta perfusion
Measurement of placental transfer.
干预措施: Sugammadex (Drug)
结局指标
主要结局
Foetal-maternal ratio of the drug
时间窗: On the same day as collection of placenta
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.
次要结局
未报告次要终点