Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maternal and neonatal serum acetaminophen level
研究概览
简要总结
This study has two aims:
- to evaluate placental transfer of acetaminophen from mother to baby transplacentally given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)
- to understand the impact of maternal acetaminophen use on fetal movement and breathing (20 patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1 (20 patients)
Pregnant women will be given a single dose of 1000 mg of acetaminophen orally after a baseline ultrasound and 60 minutes before a repeat ultrasound.
干预措施: Arm 1 (20 patients) (Drug)
Arm 2 (34 patients)
Pregnant women will be given a single dose of 1000 mg of acetaminophen orally 30 minutes to 24 hours before a scheduled cesarean section.
干预措施: Arm 2 (34 patients) (Drug)
结局指标
主要结局
Maternal and neonatal serum acetaminophen level
时间窗: Time Frame: 30 minutes to 24 hours post administration
Pregnant women will be given 1000 mg of acetaminophen orally and have both maternal and neonatal serum acetaminophen levels checked at the time of cesarean section 30 minutes to 24 hours after administration.
Fetal breathing and body movements
时间窗: Time Frame: 60 minutes
Pregnant women will have a baseline assessment of fetal breathing and body movements with ultrasound and will then be given 1000 mg of acetaminophen orally. Fetal breathing and body movements will then be reassessed 60 minutes later.
次要结局
未报告次要终点