Clinical Trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Recruiting Phase 4
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Summary
To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-05-01; most recent amendment 2026-01-23.
Status change: Not Yet Recruiting → Recruiting 2024-07-26
Trial Details
NCT Number NCT06396078
Lead Sponsor Ohio State University
Conditions Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth
Enrollment 56 participants
Start Date 2024-07-18
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-27