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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 is a Phase 1 study that has completed, run by Ohio State University. The registered enrollment target is 68 participants.

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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.

Interventions

  • PROCEDURE amniocentesis
  • DRUG N-acetylcysteine or placebo

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2006-10-01
Est. Completion 2018-08-01
Phase Phase 1

Sponsor

Ohio State University

552 total trials

What the Registry Record Tells You About NCT00397735

The ClinicalTrials.gov registry entry for NCT00397735 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which amniocentesis is the first listed.

NCT00397735 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.