Antibiotic pharmacokinetics in women with twin pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Pharmacokinetic: Differences in antibiotic concentration between twin pairs, Antibiotic cord/maternal ratio, The maternal antibiotic volume of distribution (Vd), clearance (Cl), Protein binding (PB), Placenta interstitial fluid concentration, Umbilical cord antibiotic concentration
研究概览
简要总结
Determine the antibiotic concentration in maternal blood and newborn blood (from the umbilical cord) and investigate the potential difference in antibiotic concentration between twin siblings.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with twin pregnancies and delivery through c-section between 24- 42 gestational weeks
- •Receiving one or more of the included antibiotic agents
- •Able and willing to sign the consent
- •Ages 18-55 years old
排除标准
- •Any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives
- •Patients who are not willing to sign the consent
结局指标
主要结局
Pharmacokinetic: Differences in antibiotic concentration between twin pairs, Antibiotic cord/maternal ratio, The maternal antibiotic volume of distribution (Vd), clearance (Cl), Protein binding (PB), Placenta interstitial fluid concentration, Umbilical cord antibiotic concentration
Pharmacokinetic: Differences in antibiotic concentration between twin pairs, Antibiotic cord/maternal ratio, The maternal antibiotic volume of distribution (Vd), clearance (Cl), Protein binding (PB), Placenta interstitial fluid concentration, Umbilical cord antibiotic concentration
次要结局
- Clinical descriptive endpoints: Maternal postoperative infection or sepsis, Early-onset neonatal sepsis.
- Safety endpoints: Safety and tolerability of the antibiotics will be collected to define any adverse drug reaction (clinically observed, haematological or biochemical) that is reported by the clinical staff that is suspected as being caused by any of the study antibiotics.
- Substudy endpoints: Differences in antibiotic concentration between monochorionic and dichorionic twin pairs
研究者
Department of Clinical Pharmacology
Scientific
Medical University Of Vienna