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Recruiting Phase 4 NCT06396078

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Trial Parameters

Condition Preterm Premature Rupture of Membrane
Sponsor Ohio State University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 56
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-07-18
Completion 2026-12
Interventions
Ceftriaxone 1000 MGClarithromycin 500mgMetronidazole 500 mg

Brief 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.

Eligibility Criteria

Inclusion criteria * Admitted to the inpatient unit for expectant management of PPROM until delivery * Age ≥ 18 years with the ability to provide informed consent * Gestational age between 23 0/7 and 32 6/7 weeks Exclusion criteria * Having received more than one dose of any prophylactic antibiotic * Suspected or confirmed infection requiring treatment with antibiotics * Allergy or contraindication to an antibiotic in either arm * Maternal immunosuppression

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