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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01881542
First received: June 11, 2013
Last updated: April 8, 2014
Last verified: June 2013
  Purpose

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.


Condition
Preeclampsia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • to validate a shorter urine collection time for assessment of proteinuria [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 307
Study Start Date: June 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pregnant women admitted for assessment of suspected preeclampsia

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881542

Contacts
Contact: Raed Salim, M.D. +972-54-498-6960 salim_ra@clalit.org.il
Contact: Simon Nothman, M.B.,B.S. +972-50-434-8113 simon@med.usyd.edu.au

Locations
Israel
HaEmek Medical Center Not yet recruiting
Afula, Israel
Contact: Raed Salim, M.D.    +972-54-498-6960    salim_ra@clalit.org.il   
Contact: Simon Nothman, M.B.,B.S.    +972-50-434-8113    simon@med.usyd.edu.au   
Principal Investigator: Raed Salim, M.D.         
Sub-Investigator: Simon Nothman, M.B.,B.S.         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim, M.D. HaEmek Medical Center