Ohio State University
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.
Preterm prelabor rupture of membranes (PPROM) is the most common identifiable risk factor associated with preterm birth and affects 1 in 3 pregnant individuals in the United States with spontaneous preterm birth. Individuals diagnosed with PPROM who meet criteria for expectant management are currently admitted to the hospital for observation until delivery, which is generally recommended at 34 weeks' gestation unless indicated sooner. Initially upon admission, a course of prophylactic antibiotics is administered as this has been shown to prolong pregnancy and improve neonatal outcomes. The sta…
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
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)
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