Extended azithromycin treatment in prelabor rupture of membranes at periviable gestations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, non-blinded randomized trial compares standard antibiotic therapy for PPROM with the same therapy plus seven additional doses of oral azithromycin 500 mg every other day. The goal is to see if extended azithromycin is feasible to study, and to gather preliminary data on pregnancy latency and maternal and neonatal outcomes. Participants will complete surveys about their experience and any side effects. The study will inform the design of a larger, future trial.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pittsburgh Magee-Womens Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Christina Megli, MD/PhD — University of Pittsburgh Magee-Womens Hospital
• Study coordinator: Alexa Henderson, MD
• Email: hendersona8@upmc.edu
• Phone: 9136019107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.