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临床试验/NCT02536638
NCT02536638已完成不适用

Quantitating Proteinuria During Acute Pyelonephritis In Pregnancy

MemorialCare Health System1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
24-hour urine protein

研究概览

简要总结

The purpose of this research study is to compare the amount of protein excreted by the kidneys in a 24-hour period between patients who have a kidney infection and those who do not have a kidney infection.

详细描述

Preeclampsia is a pregnancy-unique disorder that is cured only with delivery of the baby, even if the pregnancy is premature. Defined by both blood pressure and proteinuria criteria, diagnosis is often obscured by renal processes like systemic lupus erythematosus or nephrotic syndrome that increase urinary protein spillage. Proteinuria is defined as a total protein urinary excretion exceeding 300 mg in a 24-hour urine collection in pregnancy. This is suggested to be double the protein excretion in the non-pregnancy population at 150 mg/day. A mean 24-hour urine protein excretion of 204.3 mg (± 92.5) was found in the non-hypertensive pregnant population.

Physiological changes in pregnancy predispose patients to urinary tract infections; ureteral compression by the gravid uterus, progesterone-mediated slowing of ureteral peristalsis and decreased bladder tone, and mechanical compression of the bladder contribute to impaired clearance of bacteria from the urinary tract. Indeed, acute cystitis complicates 2-4% of all pregnancies. While it has been said that urinary tract infections increase proteinuria, it is unknown how much protein spillage should be expected in the general or the pregnant populations. Hence a patient with pyelonephritis may obscure the diagnosis of preeclampsia if she spills urinary protein from her infection.

The purpose of this study is to compare the mean of 24-hour urine protein in pregnant patients with and without acute pyelonephritis.

The importance of this study will be to determine if urine protein excretion is in fact increased in the setting of pyelonephritis. This will allow for reliable evaluation of urine protein during the work up for preeclampsia in those women also found having a kidney infection.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ≥ 18 years old admitted at Miller Children and Women's Hospital Long Beach Memorial Medical Center
  • Gestational age between 20 weeks and 0 days to 41 weeks and 0 days
  • Singleton pregnancy
  • Pyelonephritis group:
  • meeting 2 out of 3 criteria:
  • Fever > 100.4
  • Costovertebral angle tenderness
  • Positive urine culture - without pyelonephritis group: without acute cystitis and pyelonephritis
  • Positive culture defined as: quantitative count of ≥ 100,000 CFU/mL or single catheterized urine specimen with quantitative count of 100 CFU/mL.

排除标准

  • Chronic hypertension
  • Pre-gestational diabetes
  • Autoimmune disorders
  • Preexisting renal disease
  • Multiple gestation
  • Vaginal bleeding
  • Preeclampsia
  • Hospital admission > 3 days

结局指标

主要结局

24-hour urine protein

时间窗: 7 days

urine protein will be measured upon patient enrollment to the study (i.e. during the study enrollment hospitalization)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Chan, MD

Maternal Fetal Medicine

MemorialCare Health System

研究点 (1)

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