Predicitve Use of Spot Urine Protein/Creatinine Ratios in Preeclampsia

NCT00870428 | Unknown

• 1 other identifier: 584-08
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine protein collection. Furthermore, the investigators plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection period is predictive of the 24-hour sample. Lastly, the investigators plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-hour collection.

Conditions

Preeclampsia

Keywords

Preeclampsia; proteinuria

Outcome Measures

Primary Outcomes (1)

• To determine if protein excretion determined by spot urine protein-to-creatinine ratios are equivalent to the gold standard 24-h urine protein collections.

  24 hours

Secondary Outcomes (1)

• To see if total protein excretion obtained from shorter timed urine collections of 4- and 8-hours duration or a combination of the two tests are equivalent to a 24-h urine collection.

  4 hr, 8 hr, 24 hr

Study Arms (1)

Preeclampsia Evaluation

Patients who are admitted for the evaluation of preeclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women between 24-42 weeks who are being evaluated for preeclampsia.

You may qualify if:

• Pregnant women over the age of 18 between 24-42 weeks who are being evaluated for preeclampsia with a 24 hour urine protein

You may not qualify if:

• Patients with pre-existing proteinuria (\>300mg)
• Renal disease
• Evidence of a current or recent (within two weeks of admission) urinary tract infection

Sponsors & Collaborators

• MemorialCare: lead
• University of California, Irvine: collaborator

Study Sites (1)

Long Beach Memorial Womens Pavillion

Long Beach, California, 90806, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Proteinuria

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah Wing, MD

  Univeristy of California Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Last Updated: March 27, 2009

Record last verified: 2009-03

Locations

US (1)