Azithromycin Before Induction

Part of paid clinical trials in Colton, California.

Sponsor
Arrowhead Regional Medical Center
Study ID
NCT06543290
Phase
PHASE1
Status
Recruiting

Conditions

  • Infections

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Azithromycin Pill — DRUG
    Azithromycin 2 grams to be administered prior to start of induction for those randomized to intervention group
  • Placebo — DRUG
    4 magnesium oxide tablets prior to the start of induction for those randomized to placebo

Study Details

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.

Key Dates

Start date
Aug 7, 2023
Status verified
Sep 2025
Primary completion
Aug 7, 2026
Completion
Aug 7, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Azithromycin Arm
    Administration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once.
  • Placebo Comparator: Placebo Arm
    Administration of 4 magnesium oxide tablets prior to the start of induction , once.

Primary Outcome Measure

Change in Composite Infection [ Time Frame: Delivery and 6 weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arrowhead Regional Medical CenterColtonCalifornia92324
Kristina Nalbandyan, DO
8187306222
Kristina Roloff, DO
9514427424

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