Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-06-19
2022-12-19
Brief Summary
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Detailed Description
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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:
1. UA and PC ratio on original sample
2. UA and PC ratio with 1 mL of whole blood added
3. UA and PC ratio with 2 mL of whole blood added
4. 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. UA and PC ratio on original sample
2. UA and PC ratio with 1 mL of whole blood added
3. UA and PC ratio with 2 mL of whole blood added
4. UA and PC ratio with 5 mL of whole blood added
SCREENING
NONE
Study Groups
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UA and PC ratio on original sample
Original urine sample
No interventions assigned to this group
UA and PC ratio with 1 mL of whole blood added
1 mL of whole blood added to 20 mLs of urine
Blood draw
An additional 8 mL of blood will be drawn during routine lab collection
UA and PC ratio with 2 mL of whole blood added
2 mL of whole blood added to 20 mLs of urine
Blood draw
An additional 8 mL of blood will be drawn during routine lab collection
UA and PC ratio with 5 mL of whole blood added
5 mL of whole blood added to 20 mLs of urine
Blood draw
An additional 8 mL of blood will be drawn during routine lab collection
Interventions
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Blood draw
An additional 8 mL of blood will be drawn during routine lab collection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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University at Buffalo
OTHER
Marshall University
OTHER
Responsible Party
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Jesse Cottrell
Assistant Professor
Locations
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Marshall University School of Medicine
Huntington, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1912480
Identifier Type: -
Identifier Source: org_study_id
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