Urinary Protein to Creatinine Ratio in Term Pregnant Women

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03661749

Enrollment

240

Registered

2018-09-07

Start date

2018-09-30

Completion date

2019-11-30

Last updated

2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Complications

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.

Interventions

OTHERclean catch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 55 Years

Healthy volunteers

Inclusion criteria

* women of 37 weeks gestation or greater

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactJames N Anasti, MD

anastij@slhn.org484-526-8878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026