Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.
研究概览
简要总结
Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical cord. These cord blood samples will be sent for bioassay of penicillin levels.
详细描述
According to the CDC, before screening for GBS colonization was implemented, early onset GBS disease occurred at a rate of 1.5-2 per 1,000 live births. Antibiotic treatment for GBS colonized women according to guideline recommended by the American College of Obstetricians and Gynecologists (ACOG) decreases the risk for early onset neonatal GBS infection 10 fold. Unfortunately, many eligible women don't receive the full treatment protocol. Although the rate of early onset infection is low, the newborns of group B strep positive women who do not receive the recommended preventative antibiotics must undergo testing and extended observation.
This study will determine the level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor and compare these levels to levels of penicillin in the umbilical vein cord blood of patients treated with intravenous penicillin in labor. Comparisons will be done through literature only; there will be no intravenous penicillin administration arm of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •pregnant women admitted for delivery or for induction of labor
- •singleton pregnancy
- •18 years old or older
- •beyond 36 weeks gestation
- •able to comprehend study and give informed consent
排除标准
- •known history of beta-lactam antibiotic allergy
- •impaired renal function
- •multiple gestation
- •current use of antibiotics
- •plan to bank cord blood after delivery
研究组 & 干预措施
Oral Penicillin
2 grams of oral penicillin V given within 4 hours of delivery
干预措施: oral penicillin V (Drug)
结局指标
主要结局
The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.
时间窗: after delivery
次要结局
- Compare levels of penicillin in the umbilical cord blood of women who received oral penicillin to the levels of women who received intravenous penicillin in labor. Comparisons will be done through literature only.(after delivery)
研究者
John Uckele
Attending Physician
William Beaumont Hospitals