Azithromycin Before Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2026-08-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Pharmacy will have data set with participants idea and placebo vs study drug. All others will be blinded.

Study Groups

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Azithromycin Arm

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

Group Type ACTIVE_COMPARATOR

Azithromycin Pill

Intervention Type DRUG

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

Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Azithromycin Pill

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes