Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria

Pre-eclampsia Clinical Trial

Official title:

Random Urine Protein-creatinine Ratio to Predict Magnitude of Proteinuria in Different Severity of Pre-eclamptic Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01623791
• Other study ID #: ÇÜTFKHD
• Status: Unknown status
• Phase: N/A
• First received: June 16, 2012
• Last updated: June 19, 2012
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 209
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Proteinuria

Locations

Country	Name	City	State
Turkey	Cukurova University Faculty of Medicine	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Côté 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of significant proteinuria	Significant proteiuria:(= 300 mg/24h)	24 hour urine collection
Secondary	Predict to magnitude of total proteinuria	Total proteinuria/24 hour	24 hour