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NCT00397735 · ClinicalTrials.gov registry record · Phase 1
N-acetylcysteine in Intra-amniotic Infection/Inflammation
A Phase 1 study, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT00397735: Completed Phase 1 study, sponsored by Ohio State University.
NCT00397735 is a Phase 1 study that has completed, run by Ohio State University. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00397735, a Phase 1 study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study 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.
Primary Outcome
IVH, NEC, BPD, ROP, Sepsis, death
Interventions
- PROCEDURE amniocentesis
- DRUG N-acetylcysteine or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2006-10-01 |
| Est. Completion | 2018-08-01 |
| Phase | Phase 1 |
What the finished NCT00397735 record still lists
NCT00397735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which amniocentesis is the first listed.
NCT00397735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00397735 about?
NCT00397735 is a clinical study titled "N-acetylcysteine in Intra-amniotic Infection/Inflammation". 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 th...
What is the current status of trial NCT00397735?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2006-10-01. Estimated completion is 2018-08-01.
What interventions are being tested in trial NCT00397735?
The interventions under investigation include: amniocentesis (PROCEDURE), N-acetylcysteine or placebo (DRUG).
Who is sponsoring clinical trial NCT00397735?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00397735's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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