The Effect of Blood on the PC Ratio During Pregnancy

Proteinuria in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434845
• Other study ID #: 1912480
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2022
• Est. completion date: December 19, 2022

Study information

• Verified date: September 2022
• Source: Marshall University
• Contact: Jesse Cottrell, MD
• Phone: 304-691-1400
• Email: cottrellj[@]marshall.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Proteinuria
• Proteinuria in Pregnancy

Intervention

Other:
• Blood draw
An additional 8 mL of blood will be drawn during routine lab collection

Locations

Country	Name	City	State
United States	Marshall University School of Medicine	Huntington	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Marshall University	University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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