Standard 24-hour Urine Protein vs Shorter Period for Diagnosis of Pre-eclampsia

NCT01881542 | Completed DMC

• 1 other identifier: 0157-12-EMC
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Preeclampsia

Keywords

preeclampsia; proteinuria; urine collection

Outcome Measures

Primary Outcomes (2)

• 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

  one year

• To examine if a shorter urine collection time for assessment of proteinuria is comparable to the standard 24 hours

  one year

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women admitted for assessment of suspected preeclampsia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, Israel

Location

Related Publications (4)

• 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.

  PMID: 22939731 BACKGROUND

• Shennan 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.

  PMID: 22177535 BACKGROUND

• Adelberg 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.

  PMID: 11641655 BACKGROUND

• Kieler 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.

  PMID: 12504929 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Proteinuria

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raed Salim, M.D.

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2022-08

Locations

IL (1)