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Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients
Not Recruiting
Trial ID: NCT02427932
Purpose
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women
to that of non-pregnant women; the placental transfer over time; and the subsequent
metabolism of the transferred drug(s) in the neonate.
Official Title
PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
Stanford Investigator(s)
David Drover
Professor of Anesthesiology, Perioperative and Pain Medicine
Brendan Carvalho
Professor of Anesthesiology, Perioperative and Pain Medicine (Adult MSD) and, by courtesy, of Obstetrics and Gynecology (Maternal Fetal Medicine)
Eligibility
Inclusion Criteria:
- Generally healthy, pregnant woman (28-42 weeks)
- Generally healthy, non-pregnant female
- Scheduled to receive Ampicillin and/or Gentamicin IV
- Ages 18-55 years old
- Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by recent
blood work
- Able and willing to sign consent
Exclusion Criteria:
- Women with known renal or hepatic impairment; preeclampsia; Diabetes, including
Gestational; any medical condition that, in the opinion of the Investigator or
research team member, could potentially interfere with the study objectives
- Women who are participating in another study
- Pregnant with multiples
- BMI > 40
Intervention(s):
drug: Ampicillin
drug: Ampicillin and Gentamicin
drug: Gentamicin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Brendan Carvalho, MBBCh
650-861-8607