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Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Sponsor: Ohio State University
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.
Official title: Improvement of PPROM Management With Prophylactic Antimicrobial Therapy
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-07-18
Completion Date
2026-12
Last Updated
2026-01-27
Healthy Volunteers
No
Interventions
Ceftriaxone 1000 MG
Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)
Clarithromycin 500mg
Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)
Metronidazole 500 mg
Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)
Ampicillin 2 GM Injection
Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)
Amoxicillin 250 MG
Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)
Azithromycin
Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)
Erythromycin
Erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days (in addition to ampicillin and amoxicillin)
Locations (2)
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
University of Texas Medical Branch
Galveston, Texas, United States