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NCT01357369 · ClinicalTrials.gov registry record
Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 20
- Enrollment target
NCT01357369: Completed study, sponsored by Stanford University.
NCT01357369 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01357369 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Phlebotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-12 |
What the finished NCT01357369 record still lists
NCT01357369 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Phlebotomy is the first listed.
NCT01357369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01357369 about?
NCT01357369 is a clinical study titled "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 t...
What is the current status of trial NCT01357369?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01357369?
The interventions under investigation include: Phlebotomy (PROCEDURE).
Who is sponsoring clinical trial NCT01357369?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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