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)

Brendan Carvalho
Brendan Carvalho

Professor of Anesthesiology, Perioperative and Pain Medicine (Adult MSD) and, by courtesy, of Obstetrics and Gynecology (Maternal Fetal Medicine)

David Drover
David Drover

Professor of Anesthesiology, Perioperative and Pain 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