Clinical Trial: Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy

Brief Summary:

The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation.

The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).


Detailed Summary:
Sponsor: Saint Thomas Hospital, Panama

Current Primary Outcome: Sensitivity and Specificity [ Time Frame: Six months ]

The number of patients with a 24 hour urine collection with a proteinuria > 300mg will be compared with the number of patients with a Spot Test (protein/creatinine ratio in a random urine sample) > 0.2 (equivalent to the 24 hour test > 300 mg). This value will be used to calculate the Sensitivity and Specificity of the spot test.


Original Primary Outcome: Same as current

Current Secondary Outcome: Positive and Negative Predictive Value [ Time Frame: six months ]

The number of patients with a 24 hour urine collection with a proteinuria > 300mg will be compared with the number of patients with a Spot Test (protein/creatinine ratio in a random urine sample) > 0.2 (equivalent to the 24 hour test > 300 mg). This value will be used to calculate the positive and negative predective value of the spot test.


Original Secondary Outcome: Same as current

Information By: Saint Thomas Hospital, Panama

Dates:
Date Received: January 8, 2012
Date Started: March 2012
Date Completion: January 2016
Last Updated: January 1, 2015
Last Verified: January 2015