Clinical trial NCT06543290: Azithromycin Before Induction
Official title: Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Infections
Lead sponsor: Arrowhead Regional Medical Center
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We 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
Primary purpose: PREVENTION

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.

Detailed description: Induction rates have more than tripled in the last quarter century, and even more in the past five years in light of evidence that the 39th week is the optimal gestational age for birth. Inductions are one of the most commonly performed medical procedures, and may span several days. One of the complications associated with induction include maternal infection, which includes chorioamnionitis, endometritis, pyelonephritis, neonatal infection, perineal and cesarean wound infections. There are many well-known risk factors for these infections that include longer duration of rupture of membrane, prolonged labor, nulliparity, internal monitoring, multiple vaginal examinations and several others. Well-established guidelines are available for treating infection once diagnosed, however the role of antibiotic prophylaxis to prevent infection in patients undergoing induction of labor is less clear. In this study, we propose that administration of 2 grams oral azithromycin prior to the start of induction of labor will decrease rates of intrapartum and postpartum infections. Azithromycin is the ideal antibiotic to study in this trial since it is long acting, inexpensive, well tolerated, and has proven benefits in prior studies for prevention of obstetrical infection in cesarean deliveries and spontaneous labor. 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. Decreasing rates of infection will improve both maternal and neonatal outcomes as well as decrease hospital length of stay and associated costs.

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

Primary outcomes:
measure: Reduction in Composite Infection
timeFrame: Delivery and 6 weeks postpartum
Secondary outcomes:
measure: Reduction in Infection
timeFrame: Delivery and 6 weeks postpartum
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
Study officials:
References:
citation: Natality public-use data 2016-2018, on CDC WONDER Online Database. Division of Vital Statistics, 2020.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.