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Standard 24-hour Urine Protein vs Shorter Period for Diagnosis of Pre-eclampsia (PET and urine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01881542
Recruitment Status : Recruiting
First Posted : June 19, 2013
Last Update Posted : August 16, 2016
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel

Brief 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. 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.


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

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 307 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : July 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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

  2. To examine if a shorter urine collection time for assessment of proteinuria is comparable to the standard 24 hours [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women admitted for assessment of suspected preeclampsia

Inclusion Criteria:

  • pregnant women
  • age 18-55 years
  • blood pressure >140mmHg systolic or >90mmHg diastolic

Exclusion Criteria:

  • known renal disease
  • urinary tract infection
  • spontaneous labor or need to induce labor within the first 24 hours of admission

Information from the National Library of Medicine

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 identifier (NCT number): NCT01881542

Contact: Raed Salim, M.D. +972-54-498-6960
Contact: Simon Nothman, M.B.,B.S. +972-50-434-8113

HaEmek Medical Center Recruiting
Afula, Israel
Contact: Raed Salim, M.D.    +972-54-498-6960   
Contact: Simon Nothman, M.B.,B.S.    +972-50-434-8113   
Principal Investigator: Raed Salim, M.D.         
Sub-Investigator: Simon Nothman, M.B.,B.S.         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Principal Investigator: Raed Salim, M.D. haemek medical center