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

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357369
• Other study ID #: SU-02252011-7482
• Secondary ID: IRB 20231
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: April 19, 2016
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No