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Extended Azithromycin Treatment in Prelabor Rupture of Membranes

NCT07669207 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Preterm Prelabor Rupture of Membranes
  • PPROM

Interventions

DRUG

Azithromycin (Azithro)

Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.

DRUG

Standard Azithromycin Dosing

Oral Azithromycin 1g once.

Sponsors & Collaborators

  • Alexa Henderson

    lead OTHER

Principal Investigators

  • Christina Megli, MD/PhD · University of Pittsburgh Magee-Womens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-05-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669207 on ClinicalTrials.gov