Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Completed · Phase 1/Phase 2
Conditions studied: Chorioamnionitis, Brain Injury
In brief
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.
Key facts
- Study ID
- NCT00724594
- Run by
- Medical University of South Carolina
- People needed
- 46
- Starts
- 2008-08-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2021-04-12
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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