Pregnancy Complications
Conditions
Keywords
bacteria infections
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.
Interventions
PROCEDUREPhlebotomy
Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed