Status:
COMPLETED
N-acetylcysteine in Intra-amniotic Infection/Inflammation
Lead Sponsor:
Ohio State University
Conditions:
Labor, Premature
Preterm Premature Rupture of the Membranes
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 associate...
Detailed Description
Despite extensive research, the etiology of most preterm births remains unknown. There are significant fetal consequences associated with preterm birth, which include necrotizing enterocolitis, fetal ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00397735
Start Date
October 1 2006
End Date
August 1 2018
Last Update
October 10 2018
Active Locations (2)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43215