Urinary Protein to Creatinine Ratio in Term Pregnant Women

NCT ID: NCT03661749

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

NONE

Study Groups

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Clean catch

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

Group Type EXPERIMENTAL

clean catch

Intervention Type OTHER

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

Non-clean catch

women in this group will not employ clean catch technique

Group Type PLACEBO_COMPARATOR

clean catch

Intervention Type OTHER

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

Interventions

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clean catch

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women of 37 weeks gestation or greater

Exclusion Criteria

* Urinary tract infections
* Hypertension
* Pre-eclampsia
* Renal dysfunction
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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James Anasti, MD

Clinical Professor of OB/GYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James N Anasti, MD

Role: PRINCIPAL_INVESTIGATOR

St Luke's University Hospital

Locations

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St Luke's University Hospital

Bethlehem, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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James N Anasti, MD

Role: CONTACT

484-526-8878

Other Identifiers

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SLIR 2018-22

Identifier Type: -

Identifier Source: org_study_id

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