drugset / Trial / NCT00397735

N-acetylcysteine in Intra-amniotic Infection/Inflammation

NCT00397735

Phase 1/2 Completed 68 enrolled Ohio State University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of the study is to determine if N-acetylcysteine (a potent free radical scavenger) prevents the occurrence of adverse neonatal outcomes in preterm deliveries complicated by infection associated with preterm labor or preterm premature rupture of membranes (PPROM). The working hypothesis is that in pregnancies complicated by intra-amniotic infection or inflammation, N-acetylcysteine protects the fetus by preventing the development, or decreasing the intensity and/or progression of the fetal inflammatory syndrome.

Timeline

Start
2006-10-01
Primary completion
2012-10-29
Completion
2018-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 100 mg/kg Intravenous