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Proteinuria During Acute Pyelonephritis In Pregnancy

Quantitating Proteinuria During Acute Pyelonephritis In Pregnancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02536638
Enrollment
48
Registered
2015-09-01
Start date
2015-07-31
Completion date
2016-07-31
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proteinuria

Keywords

urine protein, pregnancy, pyelonephritis, kidney infection

Brief summary

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.

Detailed description

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.

Interventions

OTHERExposure to pyelonephritis

Pyelonephritis group are patients with exposure to pyelonephritis Without pyelonephritis group are patients without pyelonephritis

Sponsors

MemorialCare Health System
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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: 1. Fever \> 100.4 2. Costovertebral angle tenderness 3. 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
24-hour urine protein7 daysurine protein will be measured upon patient enrollment to the study (i.e. during the study enrollment hospitalization)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026