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

Trial ID or NCT#

NCT01357369

Status

not recruiting iconNOT RECRUITING

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.

Official Title

Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis

Eligibility Criteria

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
  1. - 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.)

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Contact

Martha Tingle
6507242742