Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy Complications |
Procedure: Phlebotomy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis |
- PK results for Cefazolin and Ondansetron in maternal blood specimens [ Time Frame: 10 hours ] [ Designated as safety issue: No ]Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using 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 ] [ Designated as safety issue: No ]
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 nonmem software to determine volume of distribution in L and clearance in L/minute.
- PK results of neonatal blood specimens [ Time Frame: 48 h ] [ Designated as safety issue: No ]Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonmem software to determine volume of distribution in L and clearance in L/minute.
Biospecimen Retention: Samples Without DNA
Blood samples for pharmacokinetics.
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Ondansetron/Cefazolin treatment
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.
|
Procedure: Phlebotomy
Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Generally health women at 37-42 weeks gestation, and their newborns.
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., CYP 3A4, 2D6, barbiturates, fluconazole, erythromycin, etc.)
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | David R. Drover, Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01357369 History of Changes |
| Other Study ID Numbers: | SU-02252011-7482, IRB 20231 |
| Study First Received: | May 10, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pregnancy Complications Cefazolin Ondansetron Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on May 16, 2013