Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 44 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.
 
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

Tracking Information
First Submitted Date June 16, 2012
First Posted Date June 20, 2012
Last Update Posted Date June 20, 2012
Study Start Date May 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2012)
Prediction of significant proteinuria [ Time Frame: 24 hour urine collection ]
Significant proteiuria:(≥ 300 mg/24h)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 19, 2012)
Predict to magnitude of total proteinuria [ Time Frame: 24 hour ]
Total proteinuria/24 hour
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria
Official Title Random Urine Protein-creatinine Ratio to Predict Magnitude of Proteinuria in Different Severity of Pre-eclamptic Patients
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
URINE
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.
Condition Pre-eclampsia
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 19, 2012)
209
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT01623791
Other Study ID Numbers ÇÜTFKHD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ümran Küçükgöz Güleç, Cukurova University
Study Sponsor Cukurova University
Collaborators Not Provided
Investigators
Principal Investigator: Umran Kucukgoz Gulec, Assist.Prof. Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
PRS Account Cukurova University
Verification Date June 2012