Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
|ClinicalTrials.gov Identifier: NCT01357369|
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : April 21, 2016
|Condition or disease||Intervention/treatment|
|Pregnancy Complications||Procedure: Phlebotomy|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
- 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.
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357369
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Sub-Investigator:||Brendan Carvalho||Stanford University|
|Principal Investigator:||David R. Drover||Stanford University|