Study Comparing Two Antibiotic Treatments to Improve Management of Preterm Premature Rupture of Membranes in Pregnant Women Using Ceftriaxone, Clarithromycin, and Metronidazole Versus Standard Antibiotics to Prolong Pregnancy and Improve Baby Outcomes

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.

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)