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

Completed

Conditions studied: Drug Metabolism During Pregnancy

In brief

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.

Key facts

Study ID

NCT02427932

Run by

Stanford University

People needed

45

Starts

2015-05-01

Expected to finish

2017-01-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lucille Packard Children's Hospital — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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