The Effect of Blood on the PC Ratio During Pregnancy
The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jesse Cottrell, MD
- Telefoonnummer: 304-691-1400
- E-mail: cottrellj@marshall.edu
Studie Contact Back-up
- Naam: Morgan Ruley, MS
- Telefoonnummer: 304-691-1458
- E-mail: kelley115@marshall.edu
Studie Locaties
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West Virginia
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Huntington, West Virginia, Verenigde Staten, 25701
- Werving
- Marshall University School of Medicine
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Contact:
- Jesse Cottrell, MD
- Telefoonnummer: 304-691-1460
- E-mail: cottrellje@marshall.edu
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: UA and PC ratio on original sample
Original urine sample
|
|
|
Actieve vergelijker: UA and PC ratio with 1 mL of whole blood added
1 mL of whole blood added to 20 mLs of urine
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An additional 8 mL of blood will be drawn during routine lab collection
|
|
Actieve vergelijker: UA and PC ratio with 2 mL of whole blood added
2 mL of whole blood added to 20 mLs of urine
|
An additional 8 mL of blood will be drawn during routine lab collection
|
|
Actieve vergelijker: UA and PC ratio with 5 mL of whole blood added
5 mL of whole blood added to 20 mLs of urine
|
An additional 8 mL of blood will be drawn during routine lab collection
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To measure the PC ratio after whole blood has been serially added
Tijdsspanne: 6 months
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The PC ratio is used to diagnose proteinuria in pregnancy.
Our goal is to determine if blood causes the PC ratio to be elevated.
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6 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1912480
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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