Clinical trial NCT01623791: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-eclampsia
Keywords: Pre-eclampsia
Proteinuria
Protein - creatinine ratio
Dipstick proteinuria
Severity of disease
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 209
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Prediction of significant proteinuria
timeFrame: 24 hour urine collection
Secondary outcomes:
measure: Predict to magnitude of total proteinuria
timeFrame: 24 hour
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine
Study officials:
affiliation: Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
name: Umran Kucukgoz Gulec, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cote AM, Brown MA, Lam E, von Dadelszen P, Firoz T, Liston RM, Magee LA. Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review. BMJ. 2008 May 3;336(7651):1003-6. doi: 10.1136/bmj.39532.543947.BE. Epub 2008 Apr 10.
citation: Kucukgoz Gulec U, Sucu M, Ozgunen FT, Buyukkurt S, Guzel AB, Paydas S. Spot Urine Protein-to-Creatinine Ratio to Predict the Magnitude of 24-Hour Total Proteinuria in Preeclampsia of Varying Severity. J Obstet Gynaecol Can. 2017 Oct;39(10):854-860. doi: 10.1016/j.jogc.2017.04.035. Epub 2017 Jun 21.