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

NCT ID: NCT01357369

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Pregnancy Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Phlebotomy

Intervention Type: PROCEDURE

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

Interventions

Phlebotomy

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

Intervention Type: PROCEDURE

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David R. Drover

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brendan Carvalho

Role: SUB_INVESTIGATOR

Stanford University

David R. Drover

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

IRB 20231

Identifier Type: -

Identifier Source: secondary_id

SU-02252011-7482

Identifier Type: -

Identifier Source: org_study_id