PreeclampsiaUPREENCT00654771
Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation
An observational study of Preeclampsia and Proteinuria, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Preeclampsia, Proteinuria, Hypertension
- What is being tested?
- urine collection
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.
Who may be able to join
- Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Prospective Comparison of Catheterized and Clean Catch Urine Specimens for Determination of Protein/Creatinine Ratio in Evaluation of Preeclampsia
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.
Read the detailed description
Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. However, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. At our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. However, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. Thus, 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.
- Conditions
- Preeclampsia, Proteinuria, Hypertension, Pregnancy
- Being tested
- urine collection
- Keywords
- protein/creatinine ratio, clean catch urine, catheterized urine
- Medical subject headings
- Pre-Eclampsia, Proteinuria, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine collectionOther
clean catch urine collection and catheterized urine collection
| Study group | Role | What they receive |
|---|---|---|
| 1 | women undergoing evaluation for pre-eclampsia Receives: Other: urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens
Measured: time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startJul 2005
- Primary completionMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation
- Investigators
- Beatrice A Chen, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654771
- Sponsor's protocol ID
- 0502110
- Acronym
- UPREE
- Status last verified
- Aug 2012
- First submitted
- 3 Apr 2008
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Catheterized and Clean Catch Urine Specimens for Determination of Protein/Creatinine Ratio in Evaluation of Preeclampsia
- ClinicalTrials.gov ID
- NCT00654771
- Acronym / sponsor ID
- UPREE / 0502110
- Conditions
- Preeclampsia, Proteinuria, Hypertension, Pregnancy
- Keywords
- protein/creatinine ratio, clean catch urine, catheterized urine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation
- Study start
- Jul 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. However, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. At our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. However, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. Thus, 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: urine collectionwomen undergoing evaluation for pre-eclampsia |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.
Key inclusion criteria (1 listed)
- Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine collectionclean catch urine collection and catheterized urine collection | Other | 1 |
Primary outcome
Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens
Time frame: time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice A Chen, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Proteinuria, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens (time frame: time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.