Clinical trial NCT01357369: Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
Official title: Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Keywords: bacteria infections
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally health women at 37-42 weeks gestation, and their newborns.

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.

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.)

Primary outcomes:
measure: Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens
timeFrame: 10 hours
Secondary outcomes:
measure: Identification of placental transfer of studied meds (Cefazolin and Ondansetron)
timeFrame: 1 hr
measure: PK results of neonatal blood specimens
timeFrame: 48 h
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho
role: SUB_INVESTIGATOR
affiliation: Stanford University
name: David R. Drover
role: PRINCIPAL_INVESTIGATOR
References: