Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy
Ohio State University
56 participants
Jul 18, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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
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Interventions
Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)
Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)
Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)
Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)
Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)
Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)
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)
View Full Details on ClinicalTrials.gov
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NCT06396078