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

Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications
• Intervention / Treatment: Procedure: Phlebotomy

Detailed Description

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 (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Generally health women at 37-42 weeks gestation, and their newborns.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Phlebotomy; Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hr
PK results of neonatal 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.	48 h

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: David R. Drover, Stanford University; Sub-Investigator: Brendan Carvalho, Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: bacteria infections
• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: SU-02252011-7482; IRB 20231