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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00397735 |
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 |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | November 2013 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catalin S Buhimschi, MD | 203-785-4536 | catalin.buhimschi@yale.edu |
Contact: Irina A Buhimschi, MD | 203-785-6164 | irina.buhimschi@yale.edu |
United States, Connecticut | |
Yale New Haven Hospital | Recruiting |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Catalin S Buhimschi, MD | Yale University |
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 |
pregnancy chorioamnionitis preterm labor |
preterm premature rupture of the membranes Intra-amniotic infection Intra-amniotic inflammation |
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 |
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 |