Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants Who Have Pyelonephritis
研究概览
简要总结
The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 who seek prenatal care within the University of Texas Health System with UT Physicians.
- •Urine culture of less than 100,000 CFU
排除标准
- •Less than 18 years of age
- •Risk factors to complicated UTI (including but not limited to: diverticula, urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux, ileal conduit)
- •Use of immunosuppressant drugs
- •Abnormalities of the urinary tract (including but not limited to: known ureteric or urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction, congenital anomalies, history of urological procedures)
- •History of renal disease including renal failure and transplants
- •Urine culture > 100,000 CFU of any organism
研究组 & 干预措施
Antibiotic treatment
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
干预措施: Antibiotic (Drug)
Antibiotic treatment
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
干预措施: Standard Prenatal Care (Other)
No antibiotic treatment
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
干预措施: Standard Prenatal Care (Other)
结局指标
主要结局
Number of Participants Who Have Pyelonephritis
时间窗: about 10 months
Pyelonephritis is defined as a urine culture with \>100,000 CFU with fever at any point during antenatal care.
Number of Participants Who Have Cystitis
时间窗: about 10 months
Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.
次要结局
未报告次要终点
研究者
Akwugo Adanna Eziefule
Staff Physician
The University of Texas Health Science Center, Houston