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NCT06396078 · ClinicalTrials.gov registry record · Phase 4
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
A Phase 4 study of Preterm Birth and Pregnancy, High Risk, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
- 2
- Study locations
NCT06396078: Recruiting Phase 4 study of Preterm Birth and Pregnancy, High Risk, sponsored by Ohio State University.
NCT06396078 is a Phase 4 study of Preterm Birth and Pregnancy, High Risk that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 56 participants, below the 4,408-participant average among 39 other Preterm Birth trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06396078, a Phase 4 study of Preterm Birth and Pregnancy, High Risk, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Latency will be measured in hours, and also reported as days for clinical interpretability.
Conditions Studied
Interventions
- DRUG Ceftriaxone 1000 MG
- DRUG Clarithromycin 500mg
- DRUG Metronidazole 500 mg
- DRUG Ampicillin 2 GM Injection
- DRUG Amoxicillin 250 MG
Study Locations (2)
Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT06396078 shows while recruiting
NCT06396078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 4,408-participant average among 39 other Preterm Birth trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Preterm Birth appearing as the primary indexed condition, and to 5 interventions - of which Ceftriaxone 1000 MG is the first listed.
NCT06396078 reports a single indexed study location in Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT06396078 about?
NCT06396078 is a clinical study titled "Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)". 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/amo...
What is the current status of trial NCT06396078?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2024-07-18. Estimated completion is 2026-12.
What conditions does trial NCT06396078 study?
This clinical trial studies the following conditions: Preterm Birth, Pregnancy, High Risk, Preterm Premature Rupture of Membrane.
What interventions are being tested in trial NCT06396078?
The interventions under investigation include: Ceftriaxone 1000 MG (DRUG), Clarithromycin 500mg (DRUG), Metronidazole 500 mg (DRUG), Ampicillin 2 GM Injection (DRUG), Amoxicillin 250 MG (DRUG).
Who is sponsoring clinical trial NCT06396078?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06396078 being conducted?
This trial has 2 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06396078's enrollment target sits among peer trials
56 32nd of 39 higher than 8 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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