Urinary Protein to Creatinine Ratio in Term Pregnant Women

Not Applicable

• Conditions: Pregnancy Complications
• Interventions: Other: clean catch

• Registration Number: NCT03661749
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

Brief Summary

This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.

Detailed Description

Clean catch urine should be used due to possible vaginal secretion contamination with falsely elevated U Pr/Cr ratio. However, no supporting reference was found in the article and no control group with random urine collection for comparison to clean catch specimen U Pr/Cr was included in their study. The original studies that validated spot Pr/Cr urine as a predictor of 24 -hour total urine protein used random non-clean catch random urines . They had an r value of .93-.99 in estimating total protein excreted in 24 hours. At our institution we use Siemens-base test to determine U Pr/Cr. In the product insert the company states that no special patient preparation is necessary.

Thus, this study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.

Study Timeline

• Study First Submitted: 2018-08-31
• Status Verified: 2018-09
• Study Start: 2018-09
• Study First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Study First Posted: 2018-09-07
• Last Update Posted: 2018-09-07
• Primary Completion: 2019-08
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• women of 37 weeks gestation or greater

Exclusion Criteria

• Urinary tract infections
• Hypertension
• Pre-eclampsia
• Renal dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-clean catch	clean catch	women in this group will not employ clean catch technique
Clean catch	clean catch	women in this group will collect urine for PR/CR using a clean catch technique

Primary Outcome Measures

Name	Time	Method
elevated PR/CR ratio using clean catch technique	through study completion, an average of 1 year	this will be the proportion of patients with PR/CR ratio greater than or equal to 0.3 in urine using a clean catch method.

Secondary Outcome Measures

Name	Time	Method
Report the incident of PR/CR ratio greater than 0.3	through study completion, average of 1 year	overall incident of elevated PR/CR ratio in healthy term pregnant women

Trial Locations

Locations (1)

St Luke's University Hospital; 🇺🇸 Bethlehem, Pennsylvania, United States