Azithromycin Before Induction

NCT06543290 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 23-33
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Composite Infection

  single oral dose of Azithromycin given prior to the start of induction of labor will decrease rates of composite infection

  Delivery and 6 weeks postpartum

Secondary Outcomes (1)

• Change in Infection

  Delivery and 6 weeks postpartum

Study Arms (2)

Azithromycin Arm

ACTIVE COMPARATOR

Administration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once.

Drug: Azithromycin Pill

Placebo Arm

PLACEBO COMPARATOR

Administration of 4 magnesium oxide tablets prior to the start of induction , once.

Drug: Placebo

Interventions

Azithromycin Pill DRUG

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

Azithromycin Arm

Placebo DRUG

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

RECRUITING

Related Publications (7)

• Natality public-use data 2016-2018, on CDC WONDER Online Database. Division of Vital Statistics, 2020.

  BACKGROUND

• Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

  PMID: 30089070 BACKGROUND

• Grobman WA, Caughey AB. Elective induction of labor at 39 weeks compared with expectant management: a meta-analysis of cohort studies. Am J Obstet Gynecol. 2019 Oct;221(4):304-310. doi: 10.1016/j.ajog.2019.02.046. Epub 2019 Feb 25.

  PMID: 30817905 BACKGROUND

• Woodd SL, Montoya A, Barreix M, Pi L, Calvert C, Rehman AM, Chou D, Campbell OMR. Incidence of maternal peripartum infection: A systematic review and meta-analysis. PLoS Med. 2019 Dec 10;16(12):e1002984. doi: 10.1371/journal.pmed.1002984. eCollection 2019 Dec.

  PMID: 31821329 BACKGROUND

• Tita AT, Andrews WW. Diagnosis and management of clinical chorioamnionitis. Clin Perinatol. 2010 Jun;37(2):339-54. doi: 10.1016/j.clp.2010.02.003.

  PMID: 20569811 BACKGROUND

• Pierce SL, Peck JD, Zornes C, Standerfer E, Edwards RK. Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100681. doi: 10.1016/j.ajogmf.2022.100681. Epub 2022 Jun 18.

  PMID: 35728781 BACKGROUND

• Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.

  PMID: 27682034 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Central Study Contacts

Kristina Nalbandyan, DO

CONTACT

8187306222; knalbandian@westernu.edu

Kristina Roloff, DO

CONTACT

9514427424; kristyroloff@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pharmacy will have data set with participants idea and placebo vs study drug. All others will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators propose a double blinded randomized control trial of patients scheduled to undergo induction of labor at our institution. Enrolled patients will be randomized to receive a single dose of 2 grams Azithromycin or placebo. Induction will proceed per hospital protocols and the primary and secondary outcomes will be obtained from chart review after delivery and will end 6 weeks postpartum

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 7, 2023
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): August 7, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)