Pre-eclampsiaNCT01623791
Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria
An observational study of Pre-eclampsia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pre-eclampsia
- How many people
- 209 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2011to Jun 2012
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients admitted to the University of Cukurova, School of Medicine, Department of Obstetrics and Gynecology between May 2011- May 2012 for evaluation of possible preclampsia and/or characterization of the severity of the preeclampsia were offered participation of this study.
Who may be able to join
- 16-50 years old, > 20 gestational week pregnant women pre-diagnosed preeclampsia.
- Diagnosis and follow-up performed in inpatients clinic.
Who cannot join
- The history of chronic hypertension
- The history of systemic illness such as pre-gestational diabetes, systemic lupus erythematosis , malignancies, renal disease.
- Pre-existing urinary tract infections
- Premature rupture of membranes
- Patients who have previously been enrolled in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University Faculty of Medicine
Adana, 01330
Umran Kucukgoz Gulec, Asist.Prof., 90 322 3386060 ext. 3195, ukucukgoz@yahoo.com
Umran Kucukgoz Gulec, Asist.Prof.
About this study
Official title: Random Urine Protein-creatinine Ratio to Predict Magnitude of Proteinuria in Different Severity of Pre-eclamptic Patients
The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. The cross-sectional longitudinal study design used, 209 patients with pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random urine samples were taken before the 24 hour urine collection for spot urine analysis for evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in all patients as the gold standard of the urine total proteinuria.
Read the detailed description
Group 1 consisted of mild preeclampsia and gestational preeclamptic patients and group 2 consisted of severe preeclamptic patients. The predictive values of the spot urinary dipstick proteinuria and protein/creatinin ratio were determinant and the correlations of the diagnostic test of 24 hour total proteinuria were evaluated. The correlations of the severity of the disease and the tests of the proteinuria were evaluated.
- Conditions
- Pre-eclampsia
- Keywords
- Pre-eclampsia, Proteinuria, Protein - creatinine ratio, Dipstick proteinuria, Severity of disease
- 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 |
|---|---|---|
| Group 1 | Group 1: mild pre-eclamptic group Mild and severe pre-eclampsia were defined American College of Obstetrics and Gynecology criteria (ACOG practice bulletin no. 33: diagnosis and management of preeclampsia and eclampsia. January 2002.) | |
| Group 2 | Group 2: severe pre-eclamptic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of significant proteinuria
Significant proteiuria:(≥ 300 mg/24h)
Measured: 24 hour urine collection
Secondary outcomes (1)
Predict to magnitude of total proteinuria
Total proteinuria/24 hour
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümran Küçükgöz Güleç, Cukurova University
- Investigators
- Umran Kucukgoz Gulec, Assist.Prof., Principal investigator, Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623791
- Sponsor's protocol ID
- ÇÜTFKHD
- Status last verified
- Jun 2012
- First submitted
- 16 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cote AM, Brown MA, Lam E, von Dadelszen P, Firoz T, Liston RM, Magee LA. Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review. BMJ. 2008 May 3;336(7651):1003-6. doi: 10.1136/bmj.39532.543947.BE. Epub 2008 Apr 10.
PubMed 18403498Kucukgoz Gulec U, Sucu M, Ozgunen FT, Buyukkurt S, Guzel AB, Paydas S. Spot Urine Protein-to-Creatinine Ratio to Predict the Magnitude of 24-Hour Total Proteinuria in Preeclampsia of Varying Severity. J Obstet Gynaecol Can. 2017 Oct;39(10):854-860. doi: 10.1016/j.jogc.2017.04.035. Epub 2017 Jun 21.
PubMed 28647444
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random Urine Protein-creatinine Ratio to Predict Magnitude of Proteinuria in Different Severity of Pre-eclamptic Patients
- ClinicalTrials.gov ID
- NCT01623791
- Acronym / sponsor ID
- ÇÜTFKHD
- Conditions
- Pre-eclampsia
- Keywords
- Pre-eclampsia, Proteinuria, Protein - creatinine ratio, Dipstick proteinuria, Severity of disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 20 Jun 2012 (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 aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. The cross-sectional longitudinal study design used, 209 patients with pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random urine samples were taken before the 24 hour urine collection for spot urine analysis for evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in all patients as the gold standard of the urine total proteinuria.
Detailed description
Group 1 consisted of mild preeclampsia and gestational preeclamptic patients and group 2 consisted of severe preeclamptic patients. The predictive values of the spot urinary dipstick proteinuria and protein/creatinin ratio were determinant and the correlations of the diagnostic test of 24 hour total proteinuria were evaluated. The correlations of the severity of the disease and the tests of the proteinuria were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1: mild pre-eclamptic group Mild and severe pre-eclampsia were defined American College of Obstetrics and Gynecology criteria (ACOG practice bulletin no. 33: diagnosis and management of preeclampsia and eclampsia. January 2002.) |
| Group 2 | – | –Group 2: severe pre-eclamptic group |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients admitted to the University of Cukurova, School of Medicine, Department of Obstetrics and Gynecology between May 2011- May 2012 for evaluation of possible preclampsia and/or characterization of the severity of the preeclampsia were offered participation of this study.
Key inclusion criteria (2 listed)
- 16-50 years old, > 20 gestational week pregnant women pre-diagnosed preeclampsia.
- Diagnosis and follow-up performed in inpatients clinic.
Key exclusion criteria (5 listed)
- The history of chronic hypertension
- The history of systemic illness such as pre-gestational diabetes, systemic lupus erythematosis , malignancies, renal disease.
- Pre-existing urinary tract infections
- Premature rupture of membranes
- 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.
Primary outcome
Prediction of significant proteinuria
Time frame: 24 hour urine collection
Significant proteiuria:(≥ 300 mg/24h)
1 secondary outcome
Predict to magnitude of total proteinuria
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Background: PubMed 18403498Cote AM, Brown MA, Lam E, von Dadelszen P, Firoz T, Liston RM, Magee LA. Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review. BMJ. 2008 May 3;336(7651):1003-6. doi: 10.1136/bmj.39532.543947.BE. Epub 2008 Apr 10.
- Derived from this study: PubMed 28647444Kucukgoz Gulec U, Sucu M, Ozgunen FT, Buyukkurt S, Guzel AB, Paydas S. Spot Urine Protein-to-Creatinine Ratio to Predict the Magnitude of 24-Hour Total Proteinuria in Preeclampsia of Varying Severity. J Obstet Gynaecol Can. 2017 Oct;39(10):854-860. doi: 10.1016/j.jogc.2017.04.035. Epub 2017 Jun 21.
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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.
Cukurova University Faculty of Medicine
Adana, Turkey (Türkiye)
Umran Kucukgoz Gulec, Assist.Prof. principal investigator
Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
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 Pre-eclampsia, run by Cukurova University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 20 Jun 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 Turkey (Türkiye). 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?
Prediction of significant proteinuria (time frame: 24 hour urine collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623791, which also lists 2 linked publications.
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 20 Jun 2012.