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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01508208

Enrollment

420

Registered

2012-01-11

Start date

2012-03-31

Completion date

2016-07-31

Last updated

2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pregnancy-Induced

Keywords

Hypertension, 24 hour urine protein, Protein/creatinine ratio

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).

Interventions

OTHERHypertensive 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026