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Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2025 to Dec 2026v7
  2. Site details revised at 1 of 2 sitesv6
  3. Study sites: 1 to 2v5
  4. Primary completion date: Aug 2025 to Dec 2025v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2024 to Jul 18, 2024
    • Site details revised
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06396078
Lead Sponsor Ohio State University
Conditions
(from sponsor)		 Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth
Related terms [OBSOLETE] Preterm Premature Rupture of the Membranes, Chorioamnionitis, Premature Birth
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov