Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Recruiting now · Phase 4
Conditions studied: Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth
In brief
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.
Key facts
- Study ID
- NCT06396078
- Run by
- Ohio State University
- People needed
- 56
- Starts
- 2024-07-18
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (enrolling)
- University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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