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

Study Overview
=================
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).

Official Title
-----------------
A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy

Conditions
-----------------
Hypertension, Pregnancy-Induced

Intervention / Treatment
-----------------
* Other: Hypertensive disorder of pregnancy


Participation Criteria
=================
Eligibility 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).
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hypertensive disorder of pregnancy<br>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<br>* Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | 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. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Predictive Value | 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. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, 24 hour urine protein, Protein/creatinine ratio