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

NCT01508208 | Completed

• 1 other identifier: MHST2011-07
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension, Pregnancy-Induced

Keywords

Hypertension; 24 hour urine protein; Protein/creatinine ratio

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Positive and Negative Predictive Value

  six months

Study Arms (1)

Hypertensive disorder of pregnancy

OTHER

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

Interventions

Hypertensive disorder of pregnancy OTHER

Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.

Hypertensive disorder of pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with 28 weeks or more of gestation.
• Complete collection of the 24 hour urine sample.

You may not qualify if:

• Failure to recollect the 24 hour urine sample.
• Pregestational Diabetes
• Kidney disease
• hour urine protein \> 8.0 g/dL or seric creatinine \> 2.0 mg/dL (it could indicate kidney disease).

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Osvaldo A Reyes, MD

  Saint Thomas Hospital, Panama

  PRINCIPAL INVESTIGATOR

• Joanna Buitrago, MD

  Saint Thomas Hospital, Panama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Research & Development

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: January 11, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 4, 2018

Record last verified: 2018-01

Locations

PA (1)