N-acetylcysteine in Intra-amniotic Infection/Inflammation
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Labor, Premature, Preterm Premature Rupture of the Membranes, Infection, Inflammation, Chorioamnionitis
In brief
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.
Key facts
- Study ID
- NCT00397735
- Run by
- Ohio State University
- People needed
- 68
- Starts
- 2006-10-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2018-10-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
- The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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