The Effect of Blood on the PC Ratio During Pregnancy
The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2022
CompletedFirst Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2022
CompletedSeptember 8, 2022
September 1, 2022
6 months
June 21, 2022
September 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
UA and PC ratio on original sample
NO INTERVENTIONOriginal urine sample
UA and PC ratio with 1 mL of whole blood added
ACTIVE COMPARATOR1 mL of whole blood added to 20 mLs of urine
UA and PC ratio with 2 mL of whole blood added
ACTIVE COMPARATOR2 mL of whole blood added to 20 mLs of urine
UA and PC ratio with 5 mL of whole blood added
ACTIVE COMPARATOR5 mL of whole blood added to 20 mLs of urine
Interventions
An additional 8 mL of blood will be drawn during routine lab collection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marshall Universitylead
- University at Buffalocollaborator
Study Sites (1)
Marshall University School of Medicine
Huntington, West Virginia, 25701, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 28, 2022
Study Start
June 19, 2022
Primary Completion
December 19, 2022
Study Completion
December 19, 2022
Last Updated
September 8, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
IPD will only be accessed by the IRB approved research team