search
Back to results

Urinary Protein to Creatinine Ratio in Term Pregnant Women

Primary Purpose

Pregnancy Complications

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
clean catch
Sponsored by
St. Luke's Hospital, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pregnancy Complications

Eligibility Criteria

16 Years - 55 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women of 37 weeks gestation or greater

Exclusion Criteria:

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

Sites / Locations

  • St Luke's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clean catch

Non-clean catch

Arm Description

women in this group will collect urine for PR/CR using a clean catch technique

women in this group will not employ clean catch technique

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Report the incident of PR/CR ratio greater than 0.3
overall incident of elevated PR/CR ratio in healthy term pregnant women

Full Information

First Posted
August 31, 2018
Last Updated
September 6, 2018
Sponsor
St. Luke's Hospital, Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT03661749
Brief Title
Urinary Protein to Creatinine Ratio in Term Pregnant Women
Official Title
Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital, Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clean catch
Arm Type
Experimental
Arm Description
women in this group will collect urine for PR/CR using a clean catch technique
Arm Title
Non-clean catch
Arm Type
Placebo Comparator
Arm Description
women in this group will not employ clean catch technique
Intervention Type
Other
Intervention Name(s)
clean catch
Intervention Description
clean catch technique applied to collect urine for PR/CR ratio
Primary Outcome Measure Information:
Title
elevated PR/CR ratio using clean catch technique
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Report the incident of PR/CR ratio greater than 0.3
Description
overall incident of elevated PR/CR ratio in healthy term pregnant women
Time Frame
through study completion, average of 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant females 37 weeks gestation or greater
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women of 37 weeks gestation or greater Exclusion Criteria: Urinary tract infections Hypertension Pre-eclampsia Renal dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James N Anasti, MD
Phone
484-526-8878
Email
anastij@slhn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James N Anasti, MD
Organizational Affiliation
St Luke's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Luke's University Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Urinary Protein to Creatinine Ratio in Term Pregnant Women

We'll reach out to this number within 24 hrs