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

This study is currently recruiting participants.
Verified December 2012 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: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Hypertension, Pregnancy-Induced
 Other: Hypertensive disorder of pregnancy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 420
Study Start Date: March 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508208

Locations
Panama
Saint Thomas H Recruiting
Panama, Panama
Contact: Osvaldo A Reyes, MD     o11(507)65655041     oreyespanama@yahoo.es    
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
Principal Investigator: Joanna Buitrago, MD Saint Thomas Hospital, Panama
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., Coordinator of Research & Development, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01508208     History of Changes
Other Study ID Numbers: MHST2011-07
Study First Received: January 8, 2012
Last Updated: December 3, 2012
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Hypertension
24 hour urine protein
Protein/creatinine ratio

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013