Trial record 14 of 96 for:    Open Studies | "Proteinuria"

Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria

This study is currently recruiting participants.
Verified June 2012 by Cukurova University
Sponsor:
Information provided by (Responsible Party):
Ümran Küçükgöz Güleç, Cukurova University
ClinicalTrials.gov Identifier:
NCT01623791
First received: June 16, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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
Pre-eclampsia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cukurova University:

Primary Outcome Measures:
  • Prediction of significant proteinuria [ Time Frame: 24 hour urine collection ] [ Designated as safety issue: No ]
    Significant proteiuria:(≥ 300 mg/24h)


Secondary Outcome Measures:
  • Predict to magnitude of total proteinuria [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    Total proteinuria/24 hour


Biospecimen Retention:   None Retained

URINE


Estimated Enrollment: 209
Study Start Date: May 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623791

Locations
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
Principal Investigator: Umran Kucukgoz Gulec, Assist.Prof. Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
  More Information

Publications:
Responsible Party: Ümran Küçükgöz Güleç, Asist. Prof. Dr, Cukurova University
ClinicalTrials.gov Identifier: NCT01623791     History of Changes
Other Study ID Numbers: ÇÜTFKHD
Study First Received: June 16, 2012
Last Updated: June 19, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Cukurova University:
Pre-eclampsia
Proteinuria
Protein - creatinine ratio
Dipstick proteinuria
Severity of disease

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Proteinuria
Hypertension, Pregnancy-Induced
Pregnancy Complications
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014