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Completed

NCT Number: NCT01508208

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

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).

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Key information

Conditions

Hypertension, Pregnancy-Induced Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas H

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Sensitivity and Specificity

    Time frame: 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 outcomes

  1. Positive and Negative Predictive Value

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2012
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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