Actively Recruiting
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy Comparing New and Standard Antibiotic Regimens
Led by Ohio State University · Updated on 2026-01-27
56
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new antibiotic treatment approach for pregnant individuals hospitalized with preterm prelabor rupture of membranes (PPROM) before 34 weeks of pregnancy. The study compares a seven-day course of ceftriaxone, clarithromycin, and metronidazole with the current standard antibiotic regimen of ampicillin or amoxicillin combined with azithromycin or erythromycin. The goal is to see if the new treatment can safely prolong pregnancy and reduce negative outcomes for the baby and mother. Participants will be randomly assigned to one of two groups. The intervention group will receive ceftriaxone intravenously once daily, clarithromycin by mouth twice daily, and metronidazole by mouth twice daily for seven days. The standard care group will receive ampicillin intravenously every six hours for two days followed by oral amoxicillin for five days combined with either a single dose of azithromycin or erythromycin given intravenously then orally for five days. Both treatments are given during hospital admission while awaiting delivery. Throughout the study, participants will be closely monitored from the time of randomization until delivery and up to six weeks postpartum. Researchers will track how long pregnancy lasts after starting treatment as the primary outcome. They will also assess infections, fever, surgical site complications, placental inflammation, antibiotic use after birth, and any side effects. The study aims to improve care for pregnant individuals with PPROM by finding the best antibiotic treatment strategy.
CONDITIONS
Brief Title
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to the inpatient unit for expectant management of PPROM until delivery
- Age 18 years or older with ability to provide informed consent
- Gestational age between 23 weeks 0 days and 32 weeks 6 days
You will not qualify if you...
- Received more than one dose of any prophylactic antibiotic
- Suspected or confirmed infection requiring antibiotic treatment
- Allergy or contraindication to any study antibiotic
- Maternal immunosuppression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days or until delivery
Participants receive one of two antibiotic regimens for expectant management of PPROM until delivery to prolong pregnancy and improve outcomes. The treatment involves daily administration of antibiotics for up to 7 days depending on the assigned regimen.
Daily medication administration during hospital stay
Duration - Up to 6 weeks postpartum
Participants are monitored up to 6 weeks postpartum for neonatal health and maternal infection outcomes.
Approximately 1 to 2 visits postpartum
Trial Site Locations
Total: 2 locations
1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
2
University of Texas Medical Branch
Galveston, Texas, United States, 775555
Actively Recruiting
Research Team
M
Marissa Berry, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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