Proteinuria During Acute Pyelonephritis In Pregnancy

NCT02536638 | Completed DMC

• 1 other identifier: 510-15
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Proteinuria

Keywords

urine protein; pregnancy; pyelonephritis; kidney infection

Outcome Measures

Primary Outcomes (1)

• 24-hour urine protein

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

  7 days

Study Arms (2)

Pyelonephritis Group

patients with pyelonephritis

Other: Exposure to pyelonephritis

Without pyelonephritis Group

patients without pyelonephritis

Interventions

Exposure to pyelonephritis OTHER

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

Pyelonephritis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

Miller Children's and Women's Hospital at Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Related Publications (9)

• Lindheimer MD, Kanter D. Interpreting abnormal proteinuria in pregnancy: the need for a more pathophysiological approach. Obstet Gynecol. 2010 Feb;115(2 Pt 1):365-375. doi: 10.1097/AOG.0b013e3181cb9644.

  PMID: 20093912 BACKGROUND

• Osmundson SS, Lafayette RA, Bowen RA, Roque VC, Garabedian MJ, Aziz N. Maternal proteinuria in twin compared with singleton pregnancies. Obstet Gynecol. 2014 Aug;124(2 Pt 1):332-337. doi: 10.1097/AOG.0000000000000383.

  PMID: 25004349 BACKGROUND

• Gilstrap LC 3rd, Ramin SM. Urinary tract infections during pregnancy. Obstet Gynecol Clin North Am. 2001 Sep;28(3):581-91. doi: 10.1016/s0889-8545(05)70219-9.

  PMID: 11512502 BACKGROUND

• Jolley JA, Wing DA. Pyelonephritis in pregnancy: an update on treatment options for optimal outcomes. Drugs. 2010 Sep 10;70(13):1643-55. doi: 10.2165/11538050-000000000-00000.

  PMID: 20731473 BACKGROUND

• Carter JL, Tomson CR, Stevens PE, Lamb EJ. Does urinary tract infection cause proteinuria or microalbuminuria? A systematic review. Nephrol Dial Transplant. 2006 Nov;21(11):3031-7. doi: 10.1093/ndt/gfl373. Epub 2006 Jul 22. No abstract available.

  PMID: 16861738 BACKGROUND

• Rubin RH, Shapiro ED, Andriole VT, Davis RJ, Stamm WE. Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis. 1992 Nov;15 Suppl 1:S216-27. doi: 10.1093/clind/15.supplement_1.s216.

  PMID: 1477233 BACKGROUND

• Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM; Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005 Mar 1;40(5):643-54. doi: 10.1086/427507. Epub 2005 Feb 4. No abstract available.

  PMID: 15714408 BACKGROUND

• CLARK LC, THOMPSON H, BECK EI. The excretion of creatine and creatinine during pregnancy. Am J Obstet Gynecol. 1951 Sep;62(3):576-83. doi: 10.1016/0002-9378(51)91156-8. No abstract available.

  PMID: 14877920 BACKGROUND

• Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

  PMID: 24150027 RESULT

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

MeSH Terms

Conditions

Proteinuria; Pyelonephritis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis

Study Officials

• Kenneth Chan, MD

  Maternal Fetal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)