Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates

Stanford University

Status: Completed

Conditions: Pregnancy Complications

Treatments: Procedure: Phlebotomy

Study type: Observational

Funder types: Other

Identifiers

NCT01357369

IRB 20231

SU-02252011-7482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

20 participants in 1 patient group

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.

Treatment:

Procedure: Phlebotomy