Azithromycin Before Induction

Arrowhead Regional Medical Center

Status and phase: Enrolling; Phase 1

Conditions: Infections

Treatments: Drug: Azithromycin Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT06543290

23-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Azithromycin Arm

Active Comparator group

Description:

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

Treatment:

Drug: Azithromycin Pill

Placebo Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Azithromycin Pill