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Recruiting

NCT Number: NCT06543290

Azithromycin Before Induction

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.

Recruiting

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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, the investigators 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Composite Infection

    Time frame: Delivery and 6 weeks postpartum

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

Secondary outcomes

  1. Change in Infection

    Time frame: Delivery and 6 weeks postpartum

    single oral dose of azithromycin will also decrease rates of chorioamnionitis, endometritis, wound infection (both perineal and cesarean), neonatal infection and readmission rates, pyelonephritis, endomyometritis

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Nalbandyan, DO

CONTACT

[email protected]

8187306222

Kristina Roloff, DO

CONTACT

[email protected]

9514427424

Sponsors and collaborators

Lead sponsor

Arrowhead Regional Medical Center

Other

Registry information

Official study title

Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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