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

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Hypertension, Pregnancy-Induced

Treatments: Other: Hypertensive disorder of pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT01508208

MHST2011-07

Details and patient eligibility

About

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).

Enrollment: 420 patients

Sex: Female

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

Hypertensive disorder of pregnancy

Other group

Description:

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.

Treatment:

Other: Hypertensive disorder of pregnancy