Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease brain injury in babies exposed to intrauterine infection without causing significant side effects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

Participants had all of the following to qualify:

• Chorioamnionitis, defined as either 1) clinical diagnosis of choriomanionitis 2) maternal fever greater than or equal to 100 degrees F in the presence of rupture of membranes or 2 of the following: uterine tenderness, maternal WBC > 15,000 cells/mm, fetal tachycardia > 160 bpm, malodorous amniotic fluid, or in preterm group only, rupture of membranes and active preterm labor.

• Gestational age ≥ 24 completed weeks, by first trimester ultrasound or date of last menstrual period.

• No greater than 4 hours from onset of fever or diagnosis.

Exclusion Criteria:

Participants had none of the following:

• Asthma, steroid-dependent

• Clinical sepsis, whether viral or bacterial in nature, defined as fever with signs of cardiovascular compromise in mother (blood pressure < 90/50, heart rate > 120 bpm, need for oxygen due to maternal saturations below 92%, pneumonia, pyelonephritis, or meningitis)

• Seizure disorder

• Fetal weight or biparietal diameter less than the 10th% for gestational age

• Suspected major genetic or congenital abnormality

• Fetal distress which demands immediate delivery (poor fetal biophysical profile, late decelerations, sinusoidal fetal heart rate pattern)

• Participation in another therapeutic clinical trial