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

Primary Purpose

Hypertension, Pregnancy-Induced

Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Hypertensive disorder of pregnancy
Sponsored by
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Pregnancy-Induced focused on measuring Hypertension, 24 hour urine protein, Protein/creatinine ratio

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • Saint Thomas H

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hypertensive disorder of pregnancy

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 8, 2012
Last Updated
January 2, 2018
Sponsor
Saint Thomas Hospital, Panama
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1. Study Identification

Unique Protocol Identification Number
NCT01508208
Brief Title
Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders
Official Title
A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy-Induced
Keywords
Hypertension, 24 hour urine protein, Protein/creatinine ratio

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertensive disorder of pregnancy
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Hypertensive disorder of pregnancy
Intervention Description
Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.
Primary Outcome Measure Information:
Title
Sensitivity and Specificity
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Positive and Negative Predictive Value
Description
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.
Time Frame
six months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo A Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna Buitrago, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama

12. IPD Sharing Statement

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

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