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N-Acetylcysteine in Intra-Amniotic Infection/Inflammation
This study is currently recruiting participants.
Verified by Yale University, November 2006
Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00397735
  Purpose

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.


Condition Intervention Phase
Labor, Premature
Preterm Premature Rupture of the Membranes
Infection
Inflammation
Chorioamnionitis
Procedure: amniocentesis
Drug: N-acetylcysteine or placebo
Phase I
Phase II

MedlinePlus related topics: Sepsis
Drug Information available for: Acetylcysteine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Effect of N-Acetylcysteine in Preventing Adverse Neonatal Outcomes in Women With Intra-Amniotic Infection/Inflammation

Further study details as provided by Yale University:

Primary Outcome Measures:
  • neonatal death
  • early onset neonatal sepsis

Secondary Outcome Measures:
  • maternal and umbilical cord plasma N-acetylcysteine levels
  • maternal and umbilical cord plasma antioxidant capacity
  • maternal and umbilical cord blood glutathione concentration
  • umbilical cord levels of inflammatory cytokine concentrations
  • funisitis grades
  • other neonatal outcomes (respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, late-onset sepsis, bronchopulmonary dysplasia)

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: November 2013
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 respiratory distress and intra-ventricular hemorrhage. Perinatal mortality is about 44%, 11% and 5% when deliveries occur between 25-28 weeks, 29-32 weeks and 33-34 weeks, respectively. While for many years, it was assumed that the cause of the high morbidity associated with prematurity was the birth of a neonate with a restricted adaptive capacity, it has also been suggested that part of the high perinatal morbidity was the consequence of adverse processes affecting the fetus in utero, rather than of prematurity per se. Intra-amniotic inflammation present in utero early in gestation may trigger the cascade of events leading to preterm birth (i.e. rupture of membranes, cervical ripening, uterine contractions) and provide an intrauterine milieu which is unfavorable or even harmful to the fetus.

Most living organisms have developed well-integrated, antioxidant defenses to scavenge free radicals and control their intracellular concentration. A loss of balance between free radicals and antioxidants (the redox balance) is one mechanism of cell injury in diseases associated with inflammation. N-acetylcysteine is an approved anti-oxidant medication drug used during pregnancy for treatment of mothers with acetaminophen (Tylenol) toxicity. N-acetylcysteine has been safely administered during pregnancy in over 100 women who overdosed with Tylenol and to preterm and healthy term newborns for other purposes. It is a goal of our trial to prevent free radical formation by administering N-acetylcysteine and to further study whether the outcome of preterm deliveries will improve.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397735

Contacts
Contact: Catalin S Buhimschi, MD 203-785-4536 catalin.buhimschi@yale.edu
Contact: Irina A Buhimschi, MD 203-785-6164 irina.buhimschi@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Catalin S Buhimschi, MD Yale University
  More Information

Yale University Department of Obstetrics, Gynecology and Reproductive Sciences  This link exits the ClinicalTrials.gov site
Preterm birth risk quickly evaluated by proteomic profiling  This link exits the ClinicalTrials.gov site

Study ID Numbers: 0603001228
Study First Received: November 7, 2006
Last Updated: July 26, 2007
ClinicalTrials.gov Identifier: NCT00397735  
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
pregnancy
chorioamnionitis
preterm labor
preterm premature rupture of the membranes
Intra-amniotic infection
Intra-amniotic inflammation

Study placed in the following topic categories:
Fetal Diseases
Pregnancy Complications
Obstetric Labor, Premature
Wounds and Injuries
Obstetric Labor Complications
Acetylcysteine
Disorders of Environmental Origin
Rupture
Chorioamnionitis
Fetal Membranes, Premature Rupture
N-monoacetylcystine
Inflammation

Additional relevant MeSH terms:
Placenta Diseases
Communicable Diseases
Respiratory System Agents
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Infection
Protective Agents
Antiviral Agents
Pharmacologic Actions
Pathologic Processes
Expectorants
Therapeutic Uses
Free Radical Scavengers
Antidotes

ClinicalTrials.gov processed this record on January 14, 2009