NCT06396078 Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
| NCT ID | NCT06396078 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ohio State University |
| Condition | Preterm Premature Rupture of Membrane |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 56 participants in total. It began in 2024-07-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Marissa Berry, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06396078 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preterm Premature Rupture of Membrane. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06396078 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06396078 currently recruiting?
Yes, NCT06396078 is actively recruiting participants. Contact the research team at Marissa.Berry@osumc.edu for enrollment information.
Where is the NCT06396078 trial being conducted?
This trial is being conducted at Columbus, United States, Galveston, United States.
Who is sponsoring the NCT06396078 clinical trial?
NCT06396078 is sponsored by Ohio State University. The principal investigator is Marissa Berry, MD at Ohio State University. The trial plans to enroll 56 participants.