N-acetylcysteine in Intra-amniotic Infection/Inflammation
Labor, Premature, Preterm Premature Rupture of the Membranes, Infection
About this trial
This is an interventional treatment trial for Labor, Premature focused on measuring pregnancy, chorioamnionitis, preterm labor, preterm premature rupture of the membranes, Intra-amniotic infection, Intra-amniotic inflammation
Eligibility Criteria
Inclusion Criteria:
- Women admitted onto the Labor and Birth Ward or Maternal Special Care Units of the Yale New Haven Hospital who have a clinically indicated amniocentesis which demonstrates presence of intra-amniotic infection and/or inflammation.
Exclusion Criteria:
- Patients that require immediate intervention or close medical supervision (cardiac and renal disease, congestive heart failure, history of asthma), maternal infection (HIV, hepatitis B or C), cord prolapse, known fetal malformation, allergic reactions to N-acetylcysteine, preeclampsia
Sites / Locations
- Yale New Haven Hospital
- The Research Institute at Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
N-Acetylcysteine
Placebo
The subjects enrolled in our research protocol must have evidence of infection/inflammation at amniocentesis in order to receive N-acetylcysteine. Women with positive amniocentesis results The dose of N-acetylcysteine is the one recommended to be used in humans to prevent acetaminophen toxicity: 150 mg/kg loading dose (60 min), followed by 50mg/kg IV continuous infusion rate for 4 hours, and followed by 100 mg/kg IV continuous infusion rate for the following 16 hours. Acetadote (Cumberland Pharmaceuticals) is the only FDA-approved intravenous N-acetylcysteine formulation and will be used in our study.
The subjects enrolled in our research protocol must have infection/inflammation in order to be randomized to receive N-acetylcysteine or placebo. Placebo-assigned patients will receive sodium chloride solution without N-acetylcysteine