The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.

Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Women 19 years and older

• Term (37 weeks and greater)

• Singleton gestation

• Scheduled cesarean section

• Non-laboring

• Intact membranes

Exclusion Criteria:

• < 19 years of age

• Preterm (< 37 weeks)

• Multifetal gestation

• Laboring or ruptured membranes

• Known fetal anomaly

• Oligo- or polyhydramnios

• Macrolide allergy

• Macrolide exposure within 2 weeks

• Medical co-morbidities

• Hepatic or renal impairment

• Taking medications that prolong the QT interval

• Currently taking nelfinavir, efavirenz, or flucanozole

• Structural heart defects or arrythmia