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NCT Number: NCT01357369

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Phlebotomy

Procedure

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

Primary outcomes

  1. Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens

    Time frame: 10 hours

    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 outcomes

  1. Identification of placental transfer of studied meds (Cefazolin and Ondansetron)

    Time frame: 1 hr

    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.

  2. PK results of neonatal blood specimens

    Time frame: 48 h

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 20, 2011
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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