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Proteinuria During Acute Pyelonephritis In Pregnancy

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ClinicalTrials.gov Identifier: NCT02536638
Recruitment Status : Unknown
Verified August 2015 by Kenneth Chan, MD, MemorialCare Health System.
Recruitment status was:  Recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Kenneth Chan, MD, MemorialCare Health System

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.

Condition or disease Intervention/treatment
Proteinuria Other: Exposure to pyelonephritis

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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quantitating Proteinuria During Acute Pyelonephritis In Pregnancy
Study Start Date : July 2015
Estimated Primary Completion Date : February 2017

Group/Cohort Intervention/treatment
Pyelonephritis Group
patients with pyelonephritis
Other: Exposure to pyelonephritis
Pyelonephritis group are patients with exposure to pyelonephritis Without pyelonephritis group are patients without pyelonephritis

Without pyelonephritis Group
patients without pyelonephritis



Primary Outcome Measures :
  1. 24-hour urine protein [ Time Frame: 7 days ]
    urine protein will be measured upon patient enrollment to the study (i.e. during the study enrollment hospitalization)


Biospecimen Retention:   Samples With DNA
urine collection for 24 hour urine protein and creatinine analysis urine sample for urinalysis with microscopy and culture blood for measurement of serum creatinine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted to inpatient management of acute pyelonephritis meeting the inclusion and exclusion criteria will be enrolled in the study. A 24 hour urine collection with be performed for evaluation of protein.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536638


Contacts
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Contact: Cindy T Chau, MD 5629978510 ctchau@uci.edu
Contact: Kenneth Chan, MD 5629978510 kc444chan@hotmail.com

Locations
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United States, California
Miller Children's and Women's Hospital at Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Cindy T Chau, MD    562-997-8510    ctchau@uci.edu   
Contact: Kenneth Chan, MD    5629978510    kc444chan@hotmail.com   
Sponsors and Collaborators
MemorialCare Health System
Investigators
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Principal Investigator: Kenneth Chan, MD Maternal Fetal Medicine
Publications of Results:
Other Publications:

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Responsible Party: Kenneth Chan, MD, Maternal Fetal Medicine, MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02536638    
Other Study ID Numbers: 510-15
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Kenneth Chan, MD, MemorialCare Health System:
urine protein
pregnancy
pyelonephritis
kidney infection
Additional relevant MeSH terms:
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Proteinuria
Pyelonephritis
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis