Expired Study
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Stanford, California 94305


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.


Study summary:

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.


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.)


Study is Available At:


Original ID:

SU-02252011-7482


NCT ID:

NCT01357369


Secondary ID:

IRB 20231


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Brendan Carvalho
Sub-Investigator
Stanford University

Study Dates

Start Date:January 2011
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:April 2016
Last Changed Date:April 19, 2016
First Received Date:May 10, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:PK results of neonatal blood specimens
Time Frame:48 h
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Identification of placental transfer of studied meds (Cefazolin and Ondansetron)
Time Frame:1 hr
Safety Issues:False
Description: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 model
Outcome Type:Primary Outcome
Measure:Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens
Time Frame:10 hours
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Procedure
Name:Phlebotomy
Description:Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
Arm Name:Ondansetron/Cefazolin treatment

Study Arms

Study Arm Type:Other
Arm Name:Ondansetron/Cefazolin treatment
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Blood samples for pharmacokinetics.
Study Population: Generally health women at 37-42 weeks gestation, and their newborns.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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