Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
There is very little data on drug metabolism during pregnancy, and how it may differ from the non-pregnant woman. There is even less data on placental transfer of drug to the neonate when medications are given prior to delivery. This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.
The investigators hope to learn 1) the pk profile of both drugs in pregnancy, and how it differs from the non-pregnant woman, 2) the placental transfer of both drugs, and 3) the profile of neonatal metabolism of the drug that crosses the placental barrier.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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California
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Stanford, California, Forente stater, 94305
- Stanford University School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
Adult participant:
- Age 18-45 years old
- Term pregnancy (37-42 weeks)
- Delivers by planned cesarean section, or unplanned, non-urgent cesarean section.
- Generally healthy
- Able and willing to sign informed consent
Neonatal participant:
- Male of female
- 37-42 weeks gestation
Exclusion Criteria:
- Adult:Medical condition that would effect metabolism of the study drugs
- Known allergy to either study medication
- Use of medications in the last 48 hours that might induce or inhibit metabolism of ondansetron (e.g. barbiturates, fluconazole, erythromycin, etc.)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Ondansetron/Cefazolin treatment
Pregnant women undergoing uncomplicated cesarean section deliveries who have consented to participate, and will receive Ondansetron and Cefazolin in the course of their clinical care will have PK blood samples drawn.
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Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens
Tidsramme: 10 hours
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Plasma concentrations will be reported in mg/L.
Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute.
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10 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Identification of placental transfer of studied meds (Cefazolin and Ondansetron)
Tidsramme: 1 hr
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By measuring the PK of the studied drugs in the umbilical cord sample we hope to gain information regarding placental transfer. Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute. |
1 hr
|
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PK results of neonatal blood specimens
Tidsramme: 48 h
|
Plasma concentrations will be reported in mg/L.
Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute.
|
48 h
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: David R. Drover, Stanford University
- Underetterforsker: Brendan Carvalho, Stanford University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SU-02252011-7482
- IRB 20231
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