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

Not Applicable

Completed

• Conditions: Hypertension, Pregnancy-Induced

• Registration Number: NCT01508208
• Lead Sponsor: Saint Thomas Hospital, Panama

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-01-08
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Study Start: 2012-03
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	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.

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Predictive Value	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.

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama