The Effect of Blood on the PC Ratio During Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Proteinuria in Pregnancy
• Intervention / Treatment: Other: Blood draw

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:

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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesse Cottrell, MD; Phone Number: 304-691-1400; Email: cottrellj@marshall.edu
• Study Contact Backup: Name: Morgan Ruley, MS; Phone Number: 304-691-1458; Email: kelley115@marshall.edu

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Recruiting
      • Marshall University School of Medicine
      • Contact: Jesse Cottrell, MD; Phone Number: 304-691-1460; Email: cottrellje@marshall.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marshall University
• Collaborators: University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2022
• Primary Completion (Anticipated): December 19, 2022
• Study Completion (Anticipated): December 19, 2022

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria
• Other Study ID Numbers: 1912480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be accessed by the IRB approved research team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No