RecruitingPhase 4

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

United States56 participantsStarted 2024-07-18

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Latency

Timeframe: From randomization to delivery

Trial details

NCT IDNCT06396078

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Marissa Berry, MD

614-293-4780 Marissa.Berry@osumc.edu

View on ClinicalTrials.gov More Preterm Premature Rupture of Membrane trials