Standard 24-hour Urine Protein vs Shorter Period for Diagnosis of Pre-eclampsia (PET and urine)
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|ClinicalTrials.gov Identifier: NCT01881542|
Recruitment Status : Recruiting
First Posted : June 19, 2013
Last Update Posted : August 21, 2019
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.
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.
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.
|Condition or disease|
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|Study Type :||Observational|
|Estimated Enrollment :||307 participants|
|Official Title:||Comparison of the Standard 24-hour Urine Protein With Shorter Collection Periods for the Diagnosis of Preeclampsia|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881542
|Contact: Raed Salim, M.D.||+email@example.com|
|Contact: Simon Nothman, M.B.,B.S.||+firstname.lastname@example.org|
|HaEmek Medical Center||Recruiting|
|Contact: Raed Salim, M.D. +972-54-498-6960 email@example.com|
|Contact: Simon Nothman, M.B.,B.S. +972-50-434-8113 firstname.lastname@example.org|
|Principal Investigator: Raed Salim, M.D.|
|Sub-Investigator: Simon Nothman, M.B.,B.S.|
|Principal Investigator:||Raed Salim, M.D.||haemek medical center|