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Recruiting Phase 1 NCT06543290

Azithromycin Before Induction

Trial Parameters

Condition Infections
Sponsor Arrowhead Regional Medical Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 400
Sex FEMALE
Min Age 18 Years
Max Age 45 Years
Start Date 2023-08-07
Completion 2026-08-07
Interventions
Azithromycin PillPlacebo

Brief Summary

This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection.

Eligibility Criteria

Inclusion Criteria: * • Third trimester of pregnancy defined as 28 0/7 weeks or more * Singleton pregnancy * Age 18-45 * Induction of labor initiated for medical or obstetrical reason or electively over 39 weeks of gestation * No contraindication to vaginal delivery * Reassuring fetal heart rate tracing * Able and willing to provide informed consent Exclusion Criteria: * • Does not read or write in English or Spanish * Unable or unwilling to give informed consent * Use of antibiotic or antiviral agent within the last 7 days * Evidence of active infection at the time of initiation of induction (patients with rectovaginal group B streptococcus positive results will be allowed to participate as it is a colonizing organism, unless they show evidence of active infection) * Incarcerated Women * Active substance abuse * Age \< 18

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