Urinary Protein to Creatinine Ratio in Term Pregnant Women

Pregnancy Complications Clinical Trial

Official title:

Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03661749
• Other study ID #: SLIR 2018-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: November 2019

Study information

• Verified date: September 2018
• Source: St. Luke's Hospital, Pennsylvania
• Contact: James N Anasti, MD
• Phone: 484-526-8878
• Email: anastij[@]slhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

• women of 37 weeks gestation or greater

Exclusion Criteria:

• Urinary tract infections

• Hypertension

• Pre-eclampsia

• Renal dysfunction

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Other:
• clean catch
clean catch technique applied to collect urine for PR/CR ratio

Locations

Country	Name	City	State
United States	St Luke's University Hospital	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	elevated PR/CR ratio using clean catch technique	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.	through study completion, an average of 1 year
Secondary	Report the incident of PR/CR ratio greater than 0.3	overall incident of elevated PR/CR ratio in healthy term pregnant women	through study completion, average of 1 year