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Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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.
What is being tested
- Ceftriaxone 1000 MG (drug)
- Clarithromycin 500mg (drug)
- Metronidazole 500 mg (drug)
- Ampicillin 2 GM Injection (drug)
- Amoxicillin 250 MG (drug)
- Azithromycin (drug)
Sponsor: Ohio State University · Participants: 56 · Started: Jul 18, 2024
Contact the study team
- Marissa Berry, MD · Phone: 614-293-4780
Official record on ClinicalTrials.gov — NCT06396078
Locations in the U.S.
| Ohio | The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus |
| Texas | University of Texas Medical Branch, Galveston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.