Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates

Stanford University20 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy Complications

Interventions

PhlebotomyPROCEDURE

Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens

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.

Time frame: 10 hours

Secondary Outcomes

Identification of placental transfer of studied meds (Cefazolin and Ondansetron)

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.

Time frame: 1 hr

PK results of neonatal blood specimens

Time frame: 48 h

Data from ClinicalTrials.gov

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