Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients

Trial ID or NCT#

NCT02427932

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Brendan Carvalho
Brendan Carvalho
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine (Adult MSD) and, by courtesy, of Obstetrics and Gynecology (Maternal Fetal Medicine)
David Drover
David Drover
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine

Contact us to find out if this trial is right for you.

Contact

Brendan Carvalho, MBBCh
650-861-8607

View on ClinicalTrials.gov