Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before delivery.
- •Informed consent provided for participation.
- •Cesarean delivery.
排除标准
- •Known major fetal congenital anomalies or genetic disorders.
- •Plan in place for limited neonatal resuscitation or comfort care only.
- •Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.
- •Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.
- •Fetal arrhythmia.
- •Seizure disorder.
- •Oligohydramnios due to renal anomalies or renal impairment.
- •Current or anticipated use of products that include sodium benzoate.
- •Maternal age <18 years.
- •Maternal medical conditions in which caffeine or other stimulants would be contraindicated.
- •High likelihood of receiving terbutaline.
- •Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.
- •Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
研究组 & 干预措施
Antenatal Caffeine
A single dose of caffeine citrate will be given intravenously within approximately 1 hour prior to delivery. Caffeine and metabolite levels will be measured from blood samples drawn pre-dose and post-dose in pregnant participants, from cord blood, and from the neonate.
干预措施: Caffeine citrate (Drug)
研究者
Anna Thomas
Assistant Professor of Clinical Pediatrics
Indiana University