Recruiting
Phase 1

Azithromycin

Sponsor:

Arrowhead Regional Medical Center

Code:

NCT06543290

Conditions

Infections

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Azithromycin Pill

Placebo

Study Details

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.

Conditions

Infections

Study ID

NCT06543290

Start date

Aug 7, 2023

Status verified date

Sep, 2025

Completion date

Aug 7, 2026

Anticipated

Primary completion date

Aug 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Azithromycin Pill

Azithromycin 2 grams to be administered prior to start of induction for those randomized to intervention group

Placebo

4 magnesium oxide tablets prior to the start of induction for those randomized to placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristina Nalbandyan, DO

8187306222knalbandian@westernu.edu

Kristina Roloff, DO

9514427424kristyroloff@gmail.com

Locations

Arrowhead Regional Medical Center

Recruiting

Colton, California, United States, 92324

Contacts

Kristina Nalbandyan, DO

8187306222knalbandian@westernu.edu

Kristina Roloff, DO

9514427424kristyroloff@gmail.com

More Information

Sponsor

Arrowhead Regional Medical Center

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arrowhead Regional Medical Center on 2025-09-12.