Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term Treated With Prophylactic Antibiotics Zinacef Versus Placebo

What this Trial Is About

Researchers are studying women with meconium-stained amniotic fluid at term to compare the rates of infections in mothers and newborns between those treated with the antibiotic Zinacef and those given a placebo. This randomized, double-blind clinical trial aims to better understand the link between meconium staining, chorioamnionitis, neonatal sepsis, and the impact of antibiotic treatment on these infections. The trial also examines the types of bacteria found in swab cultures from cases of chorioamnionitis relative to the treatment given. Participants are randomly assigned to one of two groups: one receives prophylactic Zinacef antibiotic treatment at a dose of 750 mg three times daily, while the other receives an intravenous saline placebo at 100 cc three times daily. The study is designed to maintain blinding so that neither participants nor researchers know which treatment is given. The intervention continues around the time of labor and delivery. During the study, women are monitored for infections within seven days after birth, fever during labor through two hours postpartum, and whether their newborns require antibiotic treatment or admission to the neonatal intensive care unit (NICU) within the first week. Various clinical assessments and swab cultures are collected to evaluate infectious outcomes. The total participation duration is centered on the peripartum period and the first week postpartum, with ongoing safety and infection monitoring.

Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo