Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders
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|ClinicalTrials.gov Identifier: NCT01508208|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 4, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pregnancy-Induced||Other: Hypertensive disorder of pregnancy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
Hypertensive disorder of pregnancy
Patients with an hypertensive disorder of pregnancy (28 weeks or more of gestation)will collect a random sample of urine for a spot test (protein/creatinine ratio) and urine for 24 hours. The level of proteinuria will be determined in this sample.
Other: Hypertensive disorder of pregnancy
Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508208
|Saint Thomas H|
|Principal Investigator:||Osvaldo A Reyes, MD||Saint Thomas Hospital, Panama|
|Principal Investigator:||Joanna Buitrago, MD||Saint Thomas Hospital, Panama|