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

Hypertension, Pregnancy-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508208
• Other study ID #: MHST2011-07
• Status: Completed
• Phase: N/A
• First received: January 8, 2012
• Last updated: January 2, 2018
• Start date: March 2012
• Est. completion date: July 2016

Study information

• Verified date: January 2018
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced

Intervention

Other:
• Hypertensive 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.

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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