PreeclampsiaNCT00870428
Predicitve Use of Spot Urine Protein/Creatinine Ratios in Preeclampsia
An observational study of Preeclampsia, run by MemorialCare at 1 site in United States.
Trial summary
The investigators intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine protein collection. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to not given
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women between 24-42 weeks who are being evaluated for preeclampsia.
Who may be able to join
- Pregnant women over the age of 18 between 24-42 weeks who are being evaluated for preeclampsia with a 24 hour urine protein
Who cannot join
- Patients with pre-existing proteinuria (>300mg)
- Renal disease
- Evidence of a current or recent (within two weeks of admission) urinary tract infection
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Long Beach Memorial Womens Pavillion
Long Beach, California, 90806
Christine Preslicka, RN, 562-933-2755, cpreslicka@memorialcare.org
About this study
Official title: The Predictive Use of Spot Urine Protein/Creatinine Ratios and Decreased Sample Collection Time in the Diagnosis of Preeclampsia
The investigators intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine protein collection. Furthermore, the investigators plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection period is predictive of the 24-hour sample. Lastly, the investigators plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-hour collection.
Read the detailed description
Preeclampsia affects approximately 5-8% of pregnancies in the United States with approximately 10% occurring before 34 weeks gestation. The diagnosis of preeclampsia is determined by the presence of hypertension with proteinuria after 20 weeks gestation. The gold standard for measuring proteinuria is a 24-h urine collection for total protein. In the non-pregnant patient, a random urinary protein-to-creatinine ratio has been shown to be a reliable indicator of significant proteinuria. The reliability of this test remains unclear in the pregnant population. Because there are relatively few studies in the pregnant population and many of these studies were poorly designed, limited by sample size, or confounded by other variables, further research in this area is still necessary. The purpose of this study is to determine if there are alternative diagnostic tools for the quantification of total protein excretion in 24-hours to aid in the diagnosis of preeclampsia that can be performed more quickly and efficiently than the gold standard 24-hour urine collection. We intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-h urine protein collection. Furthermore, we plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-h collection period is predictive of the 24-h sample. Lastly, we plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-h collection. The goal would be to make the diagnosis of preeclampsia in a more timely fashion to aid in the prevention of maternal and neonatal morbidity and mortality including eclampsia, HELLP syndrome, acute renal failure, pulmonary edema, DIC, IUGR, IUFD, intracranial bleeding and stroke, Additionally, an earlier diagnosis could also impact patient care by reducing hospital stay, nursing demands, and eliminating the need for cumbersome and likely inaccurate patient 24-h home collections.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, proteinuria
- Medical subject headings
- Pre-Eclampsia, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia Evaluation | Patients who are admitted for the evaluation of preeclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if protein excretion determined by spot urine protein-to-creatinine ratios are equivalent to the gold standard 24-h urine protein collections.
Measured: 24 hours
Secondary outcomes (1)
To see if total protein excretion obtained from shorter timed urine collections of 4- and 8-hours duration or a combination of the two tests are equivalent to a 24-h urine collection.
Measured: 4 hr, 8 hr, 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
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.
- 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MemorialCare
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Investigators
- Deborah Wing, MD, Principal investigator, Univeristy of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870428
- Sponsor's protocol ID
- 584-08
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2009
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Use of Spot Urine Protein/Creatinine Ratios and Decreased Sample Collection Time in the Diagnosis of Preeclampsia
- ClinicalTrials.gov ID
- NCT00870428
- Acronym / sponsor ID
- 584-08
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, proteinuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- MemorialCareUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- Mar 2009
- First posted
- 27 Mar 2009 (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 investigators intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine protein collection. Furthermore, the investigators plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection period is predictive of the 24-hour sample. Lastly, the investigators plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-hour collection.
Detailed description
Preeclampsia affects approximately 5-8% of pregnancies in the United States with approximately 10% occurring before 34 weeks gestation. The diagnosis of preeclampsia is determined by the presence of hypertension with proteinuria after 20 weeks gestation. The gold standard for measuring proteinuria is a 24-h urine collection for total protein. In the non-pregnant patient, a random urinary protein-to-creatinine ratio has been shown to be a reliable indicator of significant proteinuria. The reliability of this test remains unclear in the pregnant population. Because there are relatively few studies in the pregnant population and many of these studies were poorly designed, limited by sample size, or confounded by other variables, further research in this area is still necessary. The purpose of this study is to determine if there are alternative diagnostic tools for the quantification of total protein excretion in 24-hours to aid in the diagnosis of preeclampsia that can be performed more quickly and efficiently than the gold standard 24-hour urine collection. We intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-h urine protein collection. Furthermore, we plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-h collection period is predictive of the 24-h sample. Lastly, we plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-h collection. The goal would be to make the diagnosis of preeclampsia in a more timely fashion to aid in the prevention of maternal and neonatal morbidity and mortality including eclampsia, HELLP syndrome, acute renal failure, pulmonary edema, DIC, IUGR, IUFD, intracranial bleeding and stroke, Additionally, an earlier diagnosis could also impact patient care by reducing hospital stay, nursing demands, and eliminating the need for cumbersome and likely inaccurate patient 24-h home collections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia Evaluation | – | –Patients who are admitted for the evaluation of preeclampsia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women between 24-42 weeks who are being evaluated for preeclampsia.
Key inclusion criteria (1 listed)
- Pregnant women over the age of 18 between 24-42 weeks who are being evaluated for preeclampsia with a 24 hour urine protein
Key exclusion criteria (3 listed)
- Patients with pre-existing proteinuria (>300mg)
- Renal disease
- Evidence of a current or recent (within two weeks of admission) urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine if protein excretion determined by spot urine protein-to-creatinine ratios are equivalent to the gold standard 24-h urine protein collections.
Time frame: 24 hours
1 secondary outcome
To see if total protein excretion obtained from shorter timed urine collections of 4- and 8-hours duration or a combination of the two tests are equivalent to a 24-h urine collection.
Time frame: 4 hr, 8 hr, 24 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2009.
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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.
Long Beach Memorial Womens Pavillion
Long Beach, United States
Deborah Wing, MD principal investigator
Univeristy of California Irvine
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, run by MemorialCare 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 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if protein excretion determined by spot urine protein-to-creatinine ratios are equivalent to the gold standard 24-h urine protein collections. (time frame: 24 hours). 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 27 Mar 2009.