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Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria

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ClinicalTrials.gov Identifier: NCT01623791
Recruitment Status : Unknown
Verified June 2012 by Ümran Küçükgöz Güleç, Cukurova University.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Ümran Küçükgöz Güleç, Cukurova University

Study Description
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Brief Summary:
The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. The cross-sectional longitudinal study design used, 209 patients with pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random urine samples were taken before the 24 hour urine collection for spot urine analysis for evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in all patients as the gold standard of the urine total proteinuria.

Condition or disease
Pre-eclampsia

Detailed Description:
Group 1 consisted of mild preeclampsia and gestational preeclamptic patients and group 2 consisted of severe preeclamptic patients. The predictive values of the spot urinary dipstick proteinuria and protein/creatinin ratio were determinant and the correlations of the diagnostic test of 24 hour total proteinuria were evaluated. The correlations of the severity of the disease and the tests of the proteinuria were evaluated.

Study Design
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Study Type : Observational
Estimated Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Random Urine Protein-creatinine Ratio to Predict Magnitude of Proteinuria in Different Severity of Pre-eclamptic Patients
Study Start Date : May 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

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Groups and Cohorts
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Group/Cohort
Group 1
Group 1: mild pre-eclamptic group Mild and severe pre-eclampsia were defined American College of Obstetrics and Gynecology criteria (ACOG practice bulletin no. 33: diagnosis and management of preeclampsia and eclampsia. January 2002.)
Group 2
Group 2: severe pre-eclamptic group


Outcome Measures
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Primary Outcome Measures :
  1. Prediction of significant proteinuria [ Time Frame: 24 hour urine collection ]
    Significant proteiuria:(≥ 300 mg/24h)


Secondary Outcome Measures :
  1. Predict to magnitude of total proteinuria [ Time Frame: 24 hour ]
    Total proteinuria/24 hour


Biospecimen Retention:   None Retained
URINE

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the University of Cukurova, School of Medicine, Department of Obstetrics and Gynecology between May 2011- May 2012 for evaluation of possible preclampsia and/or characterization of the severity of the preeclampsia were offered participation of this study.
Criteria

Inclusion Criteria:

  • 16-50 years old, > 20 gestational week pregnant women pre-diagnosed preeclampsia.
  • Diagnosis and follow-up performed in inpatients clinic.

Exclusion Criteria:

  • The history of chronic hypertension
  • The history of systemic illness such as pre-gestational diabetes, systemic lupus erythematosis , malignancies, renal disease.
  • Pre-existing urinary tract infections
  • Premature rupture of membranes
  • Patients who have previously been enrolled in the study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623791


Locations
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Turkey
Cukurova University Faculty of Medicine Recruiting
Adana, Turkey, 01330
Contact: Umran Kucukgoz Gulec, Asist.Prof.    90 322 3386060 ext 3195    ukucukgoz@yahoo.com   
Principal Investigator: Umran Kucukgoz Gulec, Asist.Prof.         
Sub-Investigator: Fatma Tuncay Ozgunen, Prof.         
Sub-Investigator: Saime Paydas, Prof.         
Sub-Investigator: Ahmet Baris Guzel, Asist.Prof.         
Sub-Investigator: Selim Buyukkurt, Assoc.Prof         
Sub-Investigator: Ismail Cuneyt Evruke, Prof.         
Sponsors and Collaborators
Cukurova University
Investigators
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Principal Investigator: Umran Kucukgoz Gulec, Assist.Prof. Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ümran Küçükgöz Güleç, Asist. Prof. Dr, Cukurova University
ClinicalTrials.gov Identifier: NCT01623791     History of Changes
Other Study ID Numbers: ÇÜTFKHD
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012
Keywords provided by Ümran Küçükgöz Güleç, Cukurova University:
Pre-eclampsia
Proteinuria
Protein - creatinine ratio
Dipstick proteinuria
Severity of disease
Additional relevant MeSH terms:
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Proteinuria
Eclampsia
Pre-Eclampsia
Urination Disorders
Urologic Diseases
 Urological Manifestations
Signs and Symptoms
Hypertension, Pregnancy-Induced
Pregnancy Complications