NCT02962830已完成2 期
Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- fetal plasma concentrations
研究概览
简要总结
The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure.
To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Termination of pregnancy for fetal malformation
- •Gestational age > 24 weeks of gestation
排除标准
- •Multiple pregnancy
- •Allergy or contraindication to sufentanil
- •Morphinic addiction
- •fetal gastroschisis, omphalocele or swallowing disorder
- •maternal cardiac or respiratory distress
研究组 & 干预措施
Sufentanil
Experimental
干预措施: Sufentanil (Drug)
结局指标
主要结局
fetal plasma concentrations
时间窗: at 30 minutes after intra-amniotic injection
fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector)
次要结局
- amniotic fluid concentrations(Immediately within 5 min after intra-amniotic injection)
- Maternal plasma concentrations(at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection)
研究者
研究点 (1)
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