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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David R. Drover, Stanford University
ClinicalTrials.gov Identifier:
NCT01357369
First received: May 10, 2011
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Pregnancy Complications
Procedure: Phlebotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Identification of placental transfer of studied meds (Cefazolin and Ondansetron) [ Time Frame: 1 hr ] [ Designated as safety issue: No ]

    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.


  • PK results of neonatal blood specimens [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood samples for pharmacokinetics.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357369

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Sub-Investigator: Brendan Carvalho Stanford University
Principal Investigator: David R. Drover Stanford University
  More Information

No publications provided

Responsible Party: David R. Drover, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01357369     History of Changes
Other Study ID Numbers: SU-02252011-7482, IRB 20231
Study First Received: May 10, 2011
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pregnancy Complications
Cefazolin
Ondansetron
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 20, 2014