Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01447290
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2011-10-04
Brief Title:
Comparison of Random Spot Urine ProteinCreatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia
Sponsor:
Mike OCallaghan Military Hospital
Organization:
Mike OCallaghan Military Hospital
Study Overview
Official Title:
Comparison of Random Spot Urine ProteinCreatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PC Ratio
Brief Summary:
This is a non-inferiority prospective study of the relationship between the 24-hour urine protein collection and spot proteincreatinine ratio in the diagnosis of preeclampsia involving a sample of 18-45 year-old pregnant women attending the new Obstetrics orientation The investigators will follow all participants who consent to be part of this study throughout their entire pregnancy Those who get evaluated for preeclampsia will then have a PC ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine collection standard of care Those participants who are not evaluated for preeclampsia during their pregnancy will be dropped from the study
Participants evaluated for preeclampsia during the prenatal period will be asked to provide a random spot clean-catch urine sample at intervals of approximately 0 and 24 hours following the initiation of the 24-hour urine collection The patients demographic and clinical data as well as the spot proteincreatinine ratio and 24-hour urine protein will be collected and analyzed at the conclusion of the study period
Participants evaluated for preeclampsia during the prenatal period will be asked to provide a random spot clean-catch urine sample at intervals of approximately 0 and 24 hours following the initiation of the 24-hour urine collection The patients demographic and clinical data as well as the spot proteincreatinine ratio and 24-hour urine protein will be collected and analyzed at the conclusion of the study period
Detailed Description:
The investigators will recruit a total of 12000 pregnant female subjects ages 18-45 that have a confirmed positive pregnancy test and whom are attending the new Obstetrics Orientation class Subjects will be recruited from the MOFH and Eglin
Visit 1
Obtain signed Informed Consent document and HIPAA Authorization research-driven
Review Medical History and record patients age gestational age parity and presence of high-risk antepartum conditions ie chronic hypertension gestational diabetes mellitus-all classes and pre-existing renal disease standard of care
All participants who consent to be part of this study will be followed throughout their entire pregnancy birth of child Those who are identified by their primary obstetrics provider as potentially having preeclampsia will then have a PC Ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine collection see Antepartum Visit Schedule Below Those participants who are not evaluated for preeclampsia during their pregnancy will be dropped from the study at the end of their pregnancy birth of child
Antepartum Visit
Collect 24-hour protein urine standard of care
Collect spot random urine proteincreatinine ratio at 0 and 24 hours research-driven
Perform a urinalysis to identify subjects that may have a Urinary Tract Infection UTI if participant tests positive for a UTI they will be excluded from this data point however they will continue in the study and data will be collected from their subsequent urine collections given that the UTI is no longer present research-driven
Participants will be recruited from the new Obstetrics Orientation class so that baseline data may be used to compare a participants non-pregnant physiological state to later gestations ie before and during the time they develop preeclampsia Previous studies do not directly compare baseline and later gestational data that would show whether the correlation between the PC ratio and 24 hour urine protein changes or remains unchanged This data would be more clinically relevant when determining presence of preeclampsia with the understanding that the spot proteincreatinine ratio may or may not retain a strong correlation to the 24 hour urine protein during all gestational ages
Participants will be continually followed by their Primary Obstetric provider who will provide standard of care This includes notifying patients of worsening conditions of preeclampsia laboratory results all treatment for preeclampsia and all teaching involved in the diagnosis and treatment of preeclampsia
The amount of urine collected for the standard of care 24-hour urine is approximately 2000 milliliters mls of urine The amount needed in order to process a PC Ratio is approximately 10mls at 0 hours and 24 hours total of 20mls
Participants will follow the standard procedures for a 24-hour urine collection During the first urination 0 hours and the last urination 24 hours participants will pour off 50 mls into a urine cup
Each sites Laboratory will be responsible for analyzing urine samples obtained at their site for this study Samples will be labeled as they would for standard laboratory draws All Laboratories are Clinical Laboratory Improvement Amendments CLIA certified and will use these procedures when processing Laboratory specimens mentioned in this research project
SUBJECTS COMPLETING THE STUDY
Subjects participation in this study is completed at the conclusion of their pregnancy Subjects will be told the results of their protein urine and spot random urine proteincreatinine ratio by their primary obstetrics provider after each study is completed Upon completion of the study each Associate Investigator will send the de-identified data to the Principal Investigator via an encrypted email for analysis Associate Investigators are also responsible for sending the Principal Investigator all the Informed Consent and HIPAA Authorization documents via encrypted email for retention the conclusion of the study
WITHDRAWAL PROCEDURES
If at any time during the study the subject decides to withdraw from the study they may do so with no further testing required beyond that required by standard of care
DEVIATIONS
Deviations that do not increase the risks to subjects like those listed in the risks section of this protocol are to be reported to the Principal Investigator of this study the 1st workday of every month via the WHMC Tracking Log for Problems Not Requiring Immediate Reporting This is done to ensure ongoing monitoring and identification of trends that may arise
Visit 1
Obtain signed Informed Consent document and HIPAA Authorization research-driven
Review Medical History and record patients age gestational age parity and presence of high-risk antepartum conditions ie chronic hypertension gestational diabetes mellitus-all classes and pre-existing renal disease standard of care
All participants who consent to be part of this study will be followed throughout their entire pregnancy birth of child Those who are identified by their primary obstetrics provider as potentially having preeclampsia will then have a PC Ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine collection see Antepartum Visit Schedule Below Those participants who are not evaluated for preeclampsia during their pregnancy will be dropped from the study at the end of their pregnancy birth of child
Antepartum Visit
Collect 24-hour protein urine standard of care
Collect spot random urine proteincreatinine ratio at 0 and 24 hours research-driven
Perform a urinalysis to identify subjects that may have a Urinary Tract Infection UTI if participant tests positive for a UTI they will be excluded from this data point however they will continue in the study and data will be collected from their subsequent urine collections given that the UTI is no longer present research-driven
Participants will be recruited from the new Obstetrics Orientation class so that baseline data may be used to compare a participants non-pregnant physiological state to later gestations ie before and during the time they develop preeclampsia Previous studies do not directly compare baseline and later gestational data that would show whether the correlation between the PC ratio and 24 hour urine protein changes or remains unchanged This data would be more clinically relevant when determining presence of preeclampsia with the understanding that the spot proteincreatinine ratio may or may not retain a strong correlation to the 24 hour urine protein during all gestational ages
Participants will be continually followed by their Primary Obstetric provider who will provide standard of care This includes notifying patients of worsening conditions of preeclampsia laboratory results all treatment for preeclampsia and all teaching involved in the diagnosis and treatment of preeclampsia
The amount of urine collected for the standard of care 24-hour urine is approximately 2000 milliliters mls of urine The amount needed in order to process a PC Ratio is approximately 10mls at 0 hours and 24 hours total of 20mls
Participants will follow the standard procedures for a 24-hour urine collection During the first urination 0 hours and the last urination 24 hours participants will pour off 50 mls into a urine cup
Each sites Laboratory will be responsible for analyzing urine samples obtained at their site for this study Samples will be labeled as they would for standard laboratory draws All Laboratories are Clinical Laboratory Improvement Amendments CLIA certified and will use these procedures when processing Laboratory specimens mentioned in this research project
SUBJECTS COMPLETING THE STUDY
Subjects participation in this study is completed at the conclusion of their pregnancy Subjects will be told the results of their protein urine and spot random urine proteincreatinine ratio by their primary obstetrics provider after each study is completed Upon completion of the study each Associate Investigator will send the de-identified data to the Principal Investigator via an encrypted email for analysis Associate Investigators are also responsible for sending the Principal Investigator all the Informed Consent and HIPAA Authorization documents via encrypted email for retention the conclusion of the study
WITHDRAWAL PROCEDURES
If at any time during the study the subject decides to withdraw from the study they may do so with no further testing required beyond that required by standard of care
DEVIATIONS
Deviations that do not increase the risks to subjects like those listed in the risks section of this protocol are to be reported to the Principal Investigator of this study the 1st workday of every month via the WHMC Tracking Log for Problems Not Requiring Immediate Reporting This is done to ensure ongoing monitoring and identification of trends that may arise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None