Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
- Conditions
- Pregnancy Complications
- Interventions
- Procedure: Phlebotomy
- Registration Number
- NCT01357369
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ondansetron/Cefazolin treatment Phlebotomy 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.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens 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 Outcome Measures
Name Time Method PK results of neonatal blood specimens 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.
Identification of placental transfer of studied meds (Cefazolin and Ondansetron) 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.
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States