Phase 2
N=46
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Chorioamnionitis · Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00724594 ↗Enrolled (actual)
46
Serious AEs
15.2%
Results posted
Apr 2015
Primary outcome: Primary: NAC Terminal Elimination Half-life — 1.2; 7.5; 5.1 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine (Drug); Control (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NAC Terminal Elimination Half-life |
1.2; 7.5; 5.1 | — |
| PRIMARY NAC Volume of Distribution |
0.41; 0.47; 0.38 | — |
| PRIMARY NAC Total Body Clearance |
255; 45.0; 53.7 | — |
| PRIMARY NAC Concentrations |
1222; 49.0; 92.3; NA; 370.7; 639.7 | — |
| PRIMARY Placental Transfer Ratio |
1.4 | — |
| PRIMARY Maternal and Infant Mean Blood Pressure Change |
-1.2; 2.1; 1; 2 | — |
| PRIMARY Cerebral Blood Flow |
0.93; 0.89; 0.92; 0.89 | 0.9 |
| PRIMARY Prothrombin Time |
19.5; 19.0; 14.2; 14.4 | 0.9 |
| SECONDARY Magnetic Resonance Spectroscopy of Infants |
1.09; 1.34 | 0.072 |
| SECONDARY Cytokine Level IL-1Ra in Plasma |
745; 8.3 | 0.014 sig |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00724594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.