NCT02908126终止1 期
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
Oxytone Bioscience BV1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Uterine contractility: area under the curve (AUC)
研究概览
简要总结
This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, term pregnant female with a gestational age of 37-42 weeks (singleton)
- •Undergoing a planned primary and uncomplicated caesarean section (CS) for their first born under regional anaesthesia
- •Aged between 18 and 40 years (both inclusive)
- •Ability to communicate well with the Investigator and to comply with the requirements of the entire study
- •Willing to give informed consent in writing.
排除标准
- •Being obese with BMI ≥35 before pregnancy
- •History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
- •History of cervical cancer
- •History of severe infection of the uterus
- •Previous surgery of the cervix or uterus or any other (previous) condition that could interfere with the measurement of uterine contractility
- •Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator
- •Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study medication
- •Contraindications for oxytocin use
- •Hypersensitivity to the active substances or to any of the excipients of the investigational product (test product or comparator drug)
- •Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anaesthetics, vasoconstrictors/sympathomimetics and caudal anaesthetics, vasopressin-like drugs
- •Administration of any other investigational drug within 3 months before first dosing
- •Tobacco use (smoking or snuffing), currently or within the last 6 months before screening
研究组 & 干预措施
Oxytocin intravenous
Experimental
single dose of intravenous (IV) oxytocin
干预措施: Oxytocin (Drug)
Oxytocin tablet
Experimental
single dose of oxytocin tablet
干预措施: Oxytocin (Drug)
结局指标
主要结局
Uterine contractility: area under the curve (AUC)
时间窗: 3 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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