NCT00654771

Brief Summary

The purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

10 months

First QC Date

April 3, 2008

Last Update Submit

August 14, 2012

Conditions

PreeclampsiaProteinuriaHypertensionPregnancy

Keywords

protein/creatinine ratioclean catch urinecatheterized urine

Outcome Measures

Primary Outcomes (1)

  • Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens

    time of enrollment

Study Arms (1)

1

women undergoing evaluation for pre-eclampsia

Other: urine collection

Interventions

urine collectionOTHER

clean catch urine collection and catheterized urine collection

1

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.

You may qualify if:

  • Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia

You may not qualify if:

  • Ruptured membranes
  • Any vaginal bleeding or spotting
  • Pre-existing urinary tract infections or patients who are found to have a concurrent urinary tract infection upon culture of urine
  • Patients who have previously been enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pre-EclampsiaProteinuriaHypertension

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Beatrice A Chen, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

July 1, 2005

Primary Completion

May 1, 2006

Study Completion

June 1, 2006

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

US(1)