Not Yet RecruitingPhase 4

Extended Azithromycin Treatment in Prelabor Rupture of Membranes

United States30 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Capability

Timeframe: From recruitment to enrollment, up to 3 days.

Participant Eligibility

Timeframe: From recruitment until enrollment, up to 3 days.

Retention and Dropout Rates

Timeframe: From recruitment to completion of the study, up to 4 months.

Intervention Delivery

Timeframe: From recruitment to completion of intervention, up to 15 days.

Participant Acceptability

Timeframe: At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.

Data Collection Procedures

Timeframe: From recruitment to completion of postpartum period, up to 6 months.

Resource Use and Cost

Timeframe: From recruitment to postpartum period, up to 6 months.

Trial details

NCT IDNCT07669207

SponsorAlexa Henderson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Alexa Henderson, MD

9136019107 hendersona8@upmc.edu

View on ClinicalTrials.gov More Preterm Prelabor Rupture of Membranes trials