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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 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 4,628-participant average among 37 other Preterm Birth trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06396078
The ClinicalTrials.gov registry entry for NCT06396078 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,628-participant average among 37 other Preterm Birth trials with a reported enrollment target (99% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.