The Effect of Blood on the PC Ratio During Pregnancy
Primary Purpose
Proteinuria in Pregnancy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood draw
Sponsored by
About this trial
This is an interventional screening trial for Proteinuria in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks
Exclusion Criteria:
- pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
Sites / Locations
- Marshall University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
UA and PC ratio on original sample
UA and PC ratio with 1 mL of whole blood added
UA and PC ratio with 2 mL of whole blood added
UA and PC ratio with 5 mL of whole blood added
Arm Description
Original urine sample
1 mL of whole blood added to 20 mLs of urine
2 mL of whole blood added to 20 mLs of urine
5 mL of whole blood added to 20 mLs of urine
Outcomes
Primary Outcome Measures
To measure the PC ratio after whole blood has been serially added
The PC ratio is used to diagnose proteinuria in pregnancy. Our goal is to determine if blood causes the PC ratio to be elevated.
Secondary Outcome Measures
Full Information
NCT ID
NCT05434845
First Posted
June 21, 2022
Last Updated
September 6, 2022
Sponsor
Marshall University
Collaborators
University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05434845
Brief Title
The Effect of Blood on the PC Ratio During Pregnancy
Official Title
The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2022 (Actual)
Primary Completion Date
December 19, 2022 (Anticipated)
Study Completion Date
December 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshall University
Collaborators
University at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will examine the effect if blood on the the protein to creatine (PC) ratio in pregnant patients by adding blood to urine samples.
Detailed Description
The Purpose of the Research:
The purpose of this study is to examine the effect of blood on the protein to creatine (PC) ratio in pregnant patients.
The Scientific or Scholarly Rationale:
The PC ratio is used to diagnosis proteinuria in pregnancy. It is thought that blood in the urine will cause the PC ratio to be elevated but there are no current studies to prove this hypothesis.
The Procedures to be Performed:
Upon presentation to the Labor and Delivery Triage or the Antepartum Unit, patients will be enrolled in the study. Urine collection that is not needed for medical workup will be collected and saved, and an extra 8 mLs of blood will be drawn during routine lab collection by phlebotomy team. Additional lab costs will be covered by Marshall Obstetrics & Gynecology.
Lab protocol: Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio:
UA and PC ratio on original sample
UA and PC ratio with 1 mL of whole blood added
UA and PC ratio with 2 mL of whole blood added
UA and PC ratio with 5 mL of whole blood added
Subjects medical records will be reviewed for past obstetrical history after consent to be in the study.
The Risks and Potential Benefits of the Research:
Risks: 8 mLs of additional maternal blood will be drawn for study purposes. Possible risks could include pain, bleeding, fainting, bruising, infection, or hematoma (blood clot under the skin) at the injection site. Please note that routine blood would be drawn regardless of study enrollment.
Benefits: Our hypothesis is that the PC ratio will be elevated by contamination with blood. It is unknown if this hypothesis is correct.
Complete Inclusion/Exclusion Criteria (may be submitted separately if extensive):
Inclusion criteria includes patients presenting to Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks.
Exclusion criteria includes pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria in Pregnancy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio:
UA and PC ratio on original sample
UA and PC ratio with 1 mL of whole blood added
UA and PC ratio with 2 mL of whole blood added
UA and PC ratio with 5 mL of whole blood added
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UA and PC ratio on original sample
Arm Type
No Intervention
Arm Description
Original urine sample
Arm Title
UA and PC ratio with 1 mL of whole blood added
Arm Type
Active Comparator
Arm Description
1 mL of whole blood added to 20 mLs of urine
Arm Title
UA and PC ratio with 2 mL of whole blood added
Arm Type
Active Comparator
Arm Description
2 mL of whole blood added to 20 mLs of urine
Arm Title
UA and PC ratio with 5 mL of whole blood added
Arm Type
Active Comparator
Arm Description
5 mL of whole blood added to 20 mLs of urine
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
An additional 8 mL of blood will be drawn during routine lab collection
Primary Outcome Measure Information:
Title
To measure the PC ratio after whole blood has been serially added
Description
The PC ratio is used to diagnose proteinuria in pregnancy. Our goal is to determine if blood causes the PC ratio to be elevated.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of >20 weeks
Exclusion Criteria:
pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Cottrell, MD
Phone
304-691-1400
Email
cottrellj@marshall.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Morgan Ruley, MS
Phone
304-691-1458
Email
kelley115@marshall.edu
Facility Information:
Facility Name
Marshall University School of Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Cottrell, MD
Phone
304-691-1460
Email
cottrellje@marshall.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will only be accessed by the IRB approved research team
Learn more about this trial
The Effect of Blood on the PC Ratio During Pregnancy
We'll reach out to this number within 24 hrs