PreeclampsiaPET and urineNCT01881542
Standard 24-hour Urine Protein vs Shorter Period for Diagnosis of Pre-eclampsia
An observational study of Preeclampsia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Background and project rationale: Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and constitutes a leading cause of maternal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 307 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Aug 2023
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women admitted for assessment of suspected preeclampsia
Who may be able to join
- pregnant women
- age 18-55 years
- blood pressure >140mmHg systolic or >90mmHg diastolic
Who cannot join
- known renal disease
- urinary tract infection
- spontaneous labor or need to induce labor within the first 24 hours of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Standard 24-hour Urine Protein With Shorter Collection Periods for the Diagnosis of Preeclampsia
Background and project rationale:
Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to endanger the lives of both the gravida and the fetus, particularly if treatment is initiated inappropriately or in an untimely fashion.
Read more
Diagnosis of preeclampsia is dependent on the finding of proteinuria, determined as being over 300mg of protein in a 24 hours urine sample. However, urine collection spanning 24 hours sometimes constitutes a "bottleneck", extending the time to diagnosis of preeclampsia. Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring that the woman be in proximity to for collection vessel, and increases the length of her hospital admission.
The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion. Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital stay and consumption of the health system's limited resources. Further, a shorter test may reduce the discomfort associated with the 24-hour test and thus increase compliance.
Previous research has suggested that briefer tests correlate with the traditional 24 hour urine collection, however these studies were based on small study populations.
Research Objective:
To validate a brief and rapid test for the diagnosis of urinary protein excretion.
To assess whether, in women with suspected preeclampsia, a difference exists between protein excretion during the daytime and at night.
Methods:
Urine collection will be performed on pregnant women admitted for investigation of suspected preeclampsia, with volumes recorded and samples taken at 6, 12 and 24 hour intervals for assessment of urinary protein content. As such, a comparison will be made between the protein excretion after 6 and 12 hours with that over a full 24 hour period; in addition, comparison will be made between daytime and nighttime urinary protein excretion. The results will allow for assessment of whether a shorter test can substitute the full 24 hour collection in the diagnosis of preeclampsia; results of women who are shown to not suffer from preeclampsia will be used to assess whether a short test can rule out the disease. Additionally a urine sample for protein/creatinine ratio will be examined and correlated with results of the different collection periods.
Read the detailed description
Literature review and project rationale:
Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to endanger the lives of both the gravida and the fetus, particularly if treatment is initiated inappropriately or in an untimely fashion.
The diagnosis of preeclampsia is based on findings of raised blood pressure (over 140/90mmHg) and the presence of proteinuria. The accepted means of measuring proteinuria is by 24-hour urine collection, with a pathological value defined as 300mg or greater in the 24 hour period. When the proteinuria is greater than 5000mg in 24 hours, the pr-eclampsia is classified as severe and is further endangers the lives of the expectant mother and fetus and often results in early delivery.
Diagnosis and assessment of severity of preeclampsia require a timely situation assessment. Urine collection spanning 24 hours sometimes constitutes a "bottleneck", extending the time to diagnosis of preeclampsia. Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring that the woman be in proximity to for collection vessel, and increases the length of her hospital admission.
The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion. Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital stay and consumption of the health system's limited resources. Further, a shorter test may reduce the discomfort associated with the 24-hour test and thus increase compliance.
Previous research has shown that 8-hour urine collection does indeed produce results paralleling the 24-hour collection, and recent research also demonstrates concordance between 12-hour and 24-hour urine collections. That said, both these studies were based on small sample populations, fewer than 100 women. Another study of women with preeclampsia showed good correlation between the results of urinary protein in samples collected over 12 hours at night and those collected over 12 hours during daytime.
Research Assumptions:
- urine collection for a period of time less than 24 hours will reflect the degree of urinary protein excretion.
- urine collection for a period of time less than 24 hours will constitute an alternative test for 24-hour urine collection, the accepted diagnostic test today.
Research Objective:
To validate a brief and rapid test for the diagnosis of urinary protein excretion.
To assess whether, in women with suspected preeclampsia, a difference exists between protein excretion during the daytime and at night.
Methods:
Urine collection is to be performed on every pregnant admitted for investigation of suspected preeclampsia. After 6, 12 and 24 hours samples of the collected urine will be taken for protein concentration assessment. Quantitative urinary protein will be established according to urinary protein concentration and collected urine volume. Results of the tests after 6 and 12 hours will be compared to the final results after 24 hours, that being the test of choice for diagnosis of proteinuria in preeclampsia and thus the test that will determine management (according to department protocol).
Women for whom preeclampsia has been ruled out (viz, those who underwent investigation following raised BP but without a finding of proteinuria) will serve to assess the ability of a short urine collection to rule out proteinuria and, as such, preeclampsia.
So as to assess whether there is a difference between results of daytime urinary protein excretion and those at night, the urine collection will be performed in two vessels as follows:
- 8:00am - beginning of urine collection
- 2:00pm, vessel 1 - recording of collected urine volume, removal of a 10mL sample of urine for protein concentration testing.
- 8:00pm, vessel 1 - recording of total collected urine volume, removal of a 10mL sample of urine for protein concentration testing. at this point urine collection will be continued in the second vessel
- 8:00am the following morning, vessel 2 - recording of collected urine volume as of 8:00pm (the previous 12 hours), removal of a 10mL sample of urine for protein concentration testing.
- contents of the two vessels are mixed, 24 hour urine volume recorded and a 10mL sample taken, this being the sample that will establish the result of the 24 hour urine collection.
Additionally a urine sample for protein/creatinine ratio will be examined and correlated with results of the different collection periods.
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, proteinuria, urine collection
- Medical subject headings
- Pre-Eclampsia, Proteinuria
What is being measured
The primary outcome is the main question the study is designed to answer.
to validate a shorter urine collection time for assessment of proteinuria
urine collection over 6 and 12 hours to compare with results of the official 24 hours urine collection for proteinuria in the investigation of suspected preeclampsia
Measured: one year
To examine if a shorter urine collection time for assessment of proteinuria is comparable to the standard 24 hours
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, HaEmek Medical Center, Israel
- Investigators
- Raed Salim, M.D., Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881542
- Sponsor's protocol ID
- 0157-12-EMC
- Acronym
- PET and urine
- Status last verified
- Aug 2022
- First submitted
- 11 Jun 2013
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tun C, Quinones JN, Kurt A, Smulian JC, Rochon M. Comparison of 12-hour urine protein and protein:creatinine ratio with 24-hour urine protein for the diagnosis of preeclampsia. Am J Obstet Gynecol. 2012 Sep;207(3):233.e1-8. doi: 10.1016/j.ajog.2012.06.010. Epub 2012 Jun 11.
PubMed 22939731Shennan AH, Redman C, Cooper C, Milne F. Are most maternal deaths from pre-eclampsia avoidable? Lancet. 2012 May 5;379(9827):1686-7. doi: 10.1016/S0140-6736(11)60785-X. Epub 2011 Dec 14. No abstract available.
PubMed 22177535Adelberg AM, Miller J, Doerzbacher M, Lambers DS. Correlation of quantitative protein measurements in 8-, 12-, and 24-hour urine samples for the diagnosis of preeclampsia. Am J Obstet Gynecol. 2001 Oct;185(4):804-7. doi: 10.1067/mob.2001.117302.
PubMed 11641655Kieler H, Zettergren T, Svensson H, Dickman PW, Larsson A. Assessing urinary albumin excretion in pre-eclamptic women: which sample to use? BJOG. 2003 Jan;110(1):12-7.
PubMed 12504929
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Standard 24-hour Urine Protein With Shorter Collection Periods for the Diagnosis of Preeclampsia
- ClinicalTrials.gov ID
- NCT01881542
- Acronym / sponsor ID
- PET and urine / 0157-12-EMC
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, proteinuria, urine collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 19 Jun 2013 (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.
Background and project rationale:
Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to endanger the lives of both the gravida and the fetus, particularly if treatment is initiated inappropriately or in an untimely fashion.
Diagnosis of preeclampsia is dependent on the finding of proteinuria, determined as being over 300mg of protein in a 24 hours urine sample. However, urine collection spanning 24 hours sometimes constitutes a "bottleneck", extending the time to diagnosis of preeclampsia. Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring that the woman be in proximity to for collection vessel, and increases the length of her hospital admission.
The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion. Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital stay and consumption of the health system's limited resources. Further, a shorter test may reduce the discomfort associated with the 24-hour test and thus increase compliance.
Previous research has suggested that briefer tests correlate with the traditional 24 hour urine collection, however these studies were based on small study populations.
Research Objective:
To validate a brief and rapid test for the diagnosis of urinary protein excretion.
To assess whether, in women with suspected preeclampsia, a difference exists between protein excretion during the daytime and at night.
Methods:
Urine collection will be performed on pregnant women admitted for investigation of suspected preeclampsia, with volumes recorded and samples taken at 6, 12 and 24 hour intervals for assessment of urinary protein content. As such, a comparison will be made between the protein excretion after 6 and 12 hours with that over a full 24 hour period; in addition, comparison will be made between daytime and nighttime urinary protein excretion. The results will allow for assessment of whether a shorter test can substitute the full 24 hour collection in the diagnosis of preeclampsia; results of women who are shown to not suffer from preeclampsia will be used to assess whether a short test can rule out the disease. Additionally a urine sample for protein/creatinine ratio will be examined and correlated with results of the different collection periods.
Detailed description
Literature review and project rationale:
Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to endanger the lives of both the gravida and the fetus, particularly if treatment is initiated inappropriately or in an untimely fashion.
The diagnosis of preeclampsia is based on findings of raised blood pressure (over 140/90mmHg) and the presence of proteinuria. The accepted means of measuring proteinuria is by 24-hour urine collection, with a pathological value defined as 300mg or greater in the 24 hour period. When the proteinuria is greater than 5000mg in 24 hours, the pr-eclampsia is classified as severe and is further endangers the lives of the expectant mother and fetus and often results in early delivery.
Diagnosis and assessment of severity of preeclampsia require a timely situation assessment. Urine collection spanning 24 hours sometimes constitutes a "bottleneck", extending the time to diagnosis of preeclampsia. Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring that the woman be in proximity to for collection vessel, and increases the length of her hospital admission.
The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion. Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital stay and consumption of the health system's limited resources. Further, a shorter test may reduce the discomfort associated with the 24-hour test and thus increase compliance.
Previous research has shown that 8-hour urine collection does indeed produce results paralleling the 24-hour collection, and recent research also demonstrates concordance between 12-hour and 24-hour urine collections. That said, both these studies were based on small sample populations, fewer than 100 women. Another study of women with preeclampsia showed good correlation between the results of urinary protein in samples collected over 12 hours at night and those collected over 12 hours during daytime.
Research Assumptions:
- urine collection for a period of time less than 24 hours will reflect the degree of urinary protein excretion.
- urine collection for a period of time less than 24 hours will constitute an alternative test for 24-hour urine collection, the accepted diagnostic test today.
Research Objective:
To validate a brief and rapid test for the diagnosis of urinary protein excretion.
To assess whether, in women with suspected preeclampsia, a difference exists between protein excretion during the daytime and at night.
Methods:
Urine collection is to be performed on every pregnant admitted for investigation of suspected preeclampsia. After 6, 12 and 24 hours samples of the collected urine will be taken for protein concentration assessment. Quantitative urinary protein will be established according to urinary protein concentration and collected urine volume. Results of the tests after 6 and 12 hours will be compared to the final results after 24 hours, that being the test of choice for diagnosis of proteinuria in preeclampsia and thus the test that will determine management (according to department protocol).
Women for whom preeclampsia has been ruled out (viz, those who underwent investigation following raised BP but without a finding of proteinuria) will serve to assess the ability of a short urine collection to rule out proteinuria and, as such, preeclampsia.
So as to assess whether there is a difference between results of daytime urinary protein excretion and those at night, the urine collection will be performed in two vessels as follows:
- 8:00am - beginning of urine collection
- 2:00pm, vessel 1 - recording of collected urine volume, removal of a 10mL sample of urine for protein concentration testing.
- 8:00pm, vessel 1 - recording of total collected urine volume, removal of a 10mL sample of urine for protein concentration testing. at this point urine collection will be continued in the second vessel
- 8:00am the following morning, vessel 2 - recording of collected urine volume as of 8:00pm (the previous 12 hours), removal of a 10mL sample of urine for protein concentration testing.
- contents of the two vessels are mixed, 24 hour urine volume recorded and a 10mL sample taken, this being the sample that will establish the result of the 24 hour urine collection.
Additionally a urine sample for protein/creatinine ratio will be examined and correlated with results of the different collection periods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women admitted for assessment of suspected preeclampsia
Key inclusion criteria (3 listed)
- pregnant women
- age 18-55 years
- blood pressure >140mmHg systolic or >90mmHg diastolic
Key exclusion criteria (3 listed)
- known renal disease
- urinary tract infection
- spontaneous labor or need to induce labor within the first 24 hours of admission
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 validate a shorter urine collection time for assessment of proteinuria
Time frame: one year
urine collection over 6 and 12 hours to compare with results of the official 24 hours urine collection for proteinuria in the investigation of suspected preeclampsia
To examine if a shorter urine collection time for assessment of proteinuria is comparable to the standard 24 hours
Time frame: one year
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 15 Mar 2024.
- Background: PubMed 22939731Tun C, Quinones JN, Kurt A, Smulian JC, Rochon M. Comparison of 12-hour urine protein and protein:creatinine ratio with 24-hour urine protein for the diagnosis of preeclampsia. Am J Obstet Gynecol. 2012 Sep;207(3):233.e1-8. doi: 10.1016/j.ajog.2012.06.010. Epub 2012 Jun 11.
- Background: PubMed 22177535Shennan AH, Redman C, Cooper C, Milne F. Are most maternal deaths from pre-eclampsia avoidable? Lancet. 2012 May 5;379(9827):1686-7. doi: 10.1016/S0140-6736(11)60785-X. Epub 2011 Dec 14. No abstract available.
- Background: PubMed 11641655Adelberg AM, Miller J, Doerzbacher M, Lambers DS. Correlation of quantitative protein measurements in 8-, 12-, and 24-hour urine samples for the diagnosis of preeclampsia. Am J Obstet Gynecol. 2001 Oct;185(4):804-7. doi: 10.1067/mob.2001.117302.
- Background: PubMed 12504929Kieler H, Zettergren T, Svensson H, Dickman PW, Larsson A. Assessing urinary albumin excretion in pre-eclamptic women: which sample to use? BJOG. 2003 Jan;110(1):12-7.
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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.
Raed Salim, M.D. principal investigator
haemek 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, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 Israel. 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?
to validate a shorter urine collection time for assessment of proteinuria (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT01881542, which also lists 4 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 15 Mar 2024.