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Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

RecruitingPhase 4Ages 18 Years - anyFemaleOhio State University
NCT06396078 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Ceftriaxone 1000 MG
  • Clarithromycin 500mg
  • Metronidazole 500 mg
  • Ampicillin 2 GM Injection
  • Amoxicillin 250 MG
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Where

2 sites
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, United States
University of Texas Medical Branch
Galveston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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