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Trial record 2 of 46 for:    severe preeclampsia AND proteinuria

Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Ümran Küçükgöz Güleç, Cukurova University

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

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.

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01623791

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Cukurova University Faculty of Medicine Recruiting
Adana, Turkey, 01330
Contact: Umran Kucukgoz Gulec, Asist.Prof.    90 322 3386060 ext 3195   
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
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Principal Investigator: Umran Kucukgoz Gulec, Assist.Prof. Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ümran Küçükgöz Güleç, Asist. Prof. Dr, Cukurova University Identifier: NCT01623791    
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:
Protein - creatinine ratio
Dipstick proteinuria
Severity of disease
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications
Urination Disorders
Urologic Diseases
Urological Manifestations