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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01508208
First received: January 8, 2012
Last updated: June 30, 2013
Last verified: June 2013

January 8, 2012
June 30, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
Sensitivity and Specificity [ Time Frame: Six months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01508208 on ClinicalTrials.gov Archive Site
Positive and Negative Predictive Value [ Time Frame: six months ] [ Designated as safety issue: No ]
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.
Same as current
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Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders
A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy

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).

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hypertension, Pregnancy-Induced
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.
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.
Intervention: Other: Hypertensive disorder of pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women with 28 weeks or more of gestation.
  • Complete collection of the 24 hour urine sample.

Exclusion Criteria:

  • Failure to recollect the 24 hour urine sample.
  • Pregestational Diabetes
  • Kidney disease
  • 24 hour urine protein > 8.0 g/dL or seric creatinine > 2.0 mg/dL (it could indicate kidney disease).
Female
Not Provided
No
Panama
 
NCT01508208
MHST2011-07
No
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
Principal Investigator: Joanna Buitrago, MD Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP