Extended Azithromycin Treatment in Prelabor Rupture of Membranes

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Alexa Henderson
Study ID
NCT07669207
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • PPROM
  • Preterm Prelabor Rupture of Membranes

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Antibiotic Regimen
    A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days.
  • Experimental: Extended Azithromycin Regimen
    The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.

Primary Outcome Measure

Recruitment Capability [ Time Frame: From recruitment to enrollment, up to 3 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Magee-Womens HospitalPittsburghPennsylvania15217
Alexa Henderson, MD
[email protected]
9136019107
Christina Megli, MD, PhD
[email protected]
Christina Megli, MD, PhD (PRINCIPAL_INVESTIGATOR)
Alexa Henderson, MD (SUB_INVESTIGATOR)

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By research site
University of Pittsburgh Magee-Womens Hospital· Pittsburgh, PA

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