The Effect of Blood on the PC Ratio During Pregnancy

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Blood on the Protein to Creatine Ratio During Pregnancy

Conditions
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Proteinuria in Pregnancy

Intervention / Treatment
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* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: UA and PC ratio on original sample<br>Original urine sample | |
| Active Comparator: UA and PC ratio with 1 mL of whole blood added<br>1 mL of whole blood added to 20 mLs of urine | Other: Blood draw<br>* An additional 8 mL of blood will be drawn during routine lab collection<br>|
| Active Comparator: UA and PC ratio with 2 mL of whole blood added<br>2 mL of whole blood added to 20 mLs of urine | Other: Blood draw<br>* An additional 8 mL of blood will be drawn during routine lab collection<br>|
| Active Comparator: UA and PC ratio with 5 mL of whole blood added<br>5 mL of whole blood added to 20 mLs of urine | Other: Blood draw<br>* An additional 8 mL of blood will be drawn during routine lab collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |