Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397735
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2006-11-07
Brief Title:
N-acetylcysteine in Intra-amniotic InfectionInflammation
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Effect of N-acetylcysteine in Preventing Adverse Neonatal Outcomes in Women With Intra-amniotic InfectionInflammation
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor progression of the fetal inflammatory syndrome
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 ie 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 compared to a control group which will not receive placebo infusion
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 compared to a control group which will not receive placebo infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None