Clinical Trial: Standard 24-hour Urine Protein vs Shorter Period for Diagnosis of Pre-eclampsia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Comparison of the Standard 24-hour Urine Protein With Shorter Collection Periods for the Diagnosis of Preeclampsia
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.
Detailed Summary:
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 produc
Sponsor: HaEmek Medical Center, Israel
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: HaEmek Medical Center, Israel
Dates:
Date Received: June 11, 2013
Date Started: June 2013
Date Completion: September 2017
Last Updated: August 15, 2016
Last Verified: August 2016
