The Effect of Blood on the PC Ratio During Pregnancy
The Effect of Blood on the Protein to Creatine Ratio During Pregnancy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jesse Cottrell, MD
- Telefonnummer: 304-691-1400
- E-post: cottrellj@marshall.edu
Studera Kontakt Backup
- Namn: Morgan Ruley, MS
- Telefonnummer: 304-691-1458
- E-post: kelley115@marshall.edu
Studieorter
-
-
West Virginia
-
Huntington, West Virginia, Förenta staterna, 25701
- Rekrytering
- Marshall University School of Medicine
-
Kontakt:
- Jesse Cottrell, MD
- Telefonnummer: 304-691-1460
- E-post: cottrellje@marshall.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: UA and PC ratio on original sample
Original urine sample
|
|
|
Aktiv komparator: UA and PC ratio with 1 mL of whole blood added
1 mL of whole blood added to 20 mLs of urine
|
An additional 8 mL of blood will be drawn during routine lab collection
|
|
Aktiv komparator: 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
|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To measure the PC ratio after whole blood has been serially added
Tidsram: 6 months
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1912480
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .