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

NCT01357369 | Completed

• 2 other identifiers: SU-02252011-7482IRB 20231
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications

Keywords

bacteria infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  1 hr

• PK results of neonatal blood specimens

  48 h

Study Arms (1)

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

Interventions

Phlebotomy PROCEDURE

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

Ondansetron/Cefazolin treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• weeks gestation

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for pharmacokinetics.

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brendan Carvalho

  Stanford University

  SUB INVESTIGATOR

• David R. Drover

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 20, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (1)