N-acetylcysteine in Intra-amniotic Infection/Inflammation
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor, Premature; Preterm Premature Rupture of the Membranes; Infection; Inflammation; Chorioamnionitis
Intervention: amniocentesis (Procedure); N-acetylcysteine or placebo (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s): Catalin S Buhimschi, MD, Principal Investigator, Affiliation: Yale University
Overall contact: Catalin S Buhimschi, MD, Phone: 203-785-4536, Email: catalin.buhimschi@yale.edu
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 and/or progression of the fetal inflammatory syndrome.
Clinical Details
Official title: Effect of N-acetylcysteine in Preventing Adverse Neonatal Outcomes in Women With Intra-amniotic Infection/Inflammation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: early onset neonatal sepsis
Secondary outcome: maternal and umbilical cord plasma N-acetylcysteine levelsmaternal 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)
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 compared to a control
group which will not receive placebo infusion
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Catalin S Buhimschi, MD, Phone: 203-785-4536, Email: catalin.buhimschi@yale.edu
Yale New Haven Hospital, New Haven, Connecticut 06510, United States; Recruiting
Additional Information
Yale University Department of Obstetrics, Gynecology and Reproductive Sciences Preterm birth risk quickly evaluated by proteomic profiling
Starting date: October 2006
Last updated: July 18, 2012
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