Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria

NCT01623791 | Unknown DMC

• 1 other identifier: ÇÜTFKHD
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-eclampsia

Keywords

Pre-eclampsia; Proteinuria; Protein - creatinine ratio; Dipstick proteinuria; Severity of disease

Outcome Measures

Primary Outcomes (1)

• Prediction of significant proteinuria

  Significant proteiuria:(≥ 300 mg/24h)

  24 hour urine collection

Secondary Outcomes (1)

• Predict to magnitude of total proteinuria

  24 hour

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• years old, \> 20 gestational week pregnant women pre-diagnosed preeclampsia.
• Diagnosis and follow-up performed in inpatients clinic.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Medicine

Adana, 01330, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 18403498 BACKGROUND

• 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.

  PMID: 28647444 DERIVED

Biospecimen

Retention: NONE RETAINED

URINE

MeSH Terms

Conditions

Pre-Eclampsia; Proteinuria

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Umran Kucukgoz Gulec, Assist.Prof.

  Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Prof. Dr

Study Record Dates

• First Submitted: June 16, 2012
• First Posted: June 20, 2012
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

TU (1)