Actively Recruiting
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Led by Ohio State University · Updated on 2026-01-27
56
Participants Needed
2
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to the inpatient unit for expectant management of PPROM until delivery
- Age 18 years or older with the ability to provide informed consent
- Gestational age between 23 0/7 and 32 6/7 weeks
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
2
University of Texas Medical Branch
Galveston, Texas, United States, 775555
Actively Recruiting
Research Team
M
Marissa Berry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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