RECRUITING Phase 4 ClinicalTrials.gov

Extended Azithromycin Treatment in Prelabor Rupture of Membranes

Sponsor: Alexa Henderson • ClinicalTrials.gov ID: NCT07669207

Registry updated: 2026-09-04

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Description

The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age. Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin. Participants will: * Be randomly assigned to one of two groups: * The standard antibiotic treatment * The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day. * Participants will be asked to complete a survey regarding their experience and side effects.

Interventions

Azithromycin (Azithro) (Drug)
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
Standard Azithromycin Dosing (Drug)
Oral Azithromycin 1g once.

Eligibility criteria

Inclusion Criteria: * Singleton gestation * Gestational age at time of PPROM between 22w0d and 28w0d * Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care) * Remain pregnant 48 hours after presentation. * Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included. * Pregnant patients below the age of 18 are eligible. Exclusion Criteria: * Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption) * Lethal congenital defects * Multiple gestation * Ongoing alternative antibiotic treatment * Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic * History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin * Known prolongation of QT interval * History of torsades de pointes * Congenital long QT syndrome * Bradyarrhythmia * Decompensated heart failure * Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents * Impaired hepatic function * GFR\<10 mL/min * Diagnosis of myasthenia gravis

Conditions

Preterm Prelabor Rupture of Membranes PPROM

Locations

University of Pittsburgh Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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