The Effect of Blood on the PC Ratio During Pregnancy
The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
Studieoversikt
Detaljert beskrivelse
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
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jesse Cottrell, MD
- Telefonnummer: 304-691-1400
- E-post: cottrellj@marshall.edu
Studer Kontakt Backup
- Navn: Morgan Ruley, MS
- Telefonnummer: 304-691-1458
- E-post: kelley115@marshall.edu
Studiesteder
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West Virginia
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Huntington, West Virginia, Forente stater, 25701
- Rekruttering
- Marshall University School of Medicine
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Ta kontakt med:
- Jesse Cottrell, MD
- Telefonnummer: 304-691-1460
- E-post: cottrellje@marshall.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: UA and PC ratio on original sample
Original urine sample
|
|
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Aktiv komparator: 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
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Aktiv komparator: UA and PC ratio with 2 mL of whole blood added
2 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
|
|
Aktiv komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To measure the PC ratio after whole blood has been serially added
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1912480
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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