Clinical trialNCT00700219UnknownObservational

Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes

SponsorProteoGenix, Inc.Enrollment900Intra-amniotic Infection

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. The specimens collected will be used to develop a specific biomarker panel and algorithm using immunoassays for optimal detection of intra-amniotic infection in women with preterm labor and intact amniotic membranes.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrew Combs, MD, PhD
Obstetrix Medical Group of California
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Banner Desert Memorial Medical Center
Mesa, Arizona, United States
William Clewell, MD
Recruiting
Banner Good Samaritan Hospital
Phoenix, Arizona, United States
William Clewell, MD
Recruiting
Tucson Medical Center
Tucson, Arizona, United States
Hugh Miller, MD
Recruiting
Long Beach Memorial Hospital
Long Beach, California, United States
Michael Nageotte, MD
Recruiting
Good Samaritan Hospital
San Jose, California, United States
Andrew Combs, MD, PhD
Recruiting
Presbyterian St. Luke'S Medical Center
Denver, Colorado, United States
Richard Porecco, MD
Recruiting
Swedish Medical Center
Englewood, Colorado, United States
Withdrawn
Indiana University School of Medicine
Indianapolis, Indiana, United States
David Haas, MD
Recruiting
Norton Downtown
Louisville, Kentucky, United States
Helen How, MD
Recruiting
St. Louis University School of Medicine
St Louis, Missouri, United States
Erol Amon, MD
Recruiting
Cooper University Hospital
Camden, New Jersey, United States
Thomas Westover, MD
Recruiting
Mount Sinai School of Medicine
New York, New York, United States
Keith Eddleman, MD
Recruiting
Carolinas Medical Center /dept. Ob/gyn
Charlotte, North Carolina, United States
Albert Franco, MD
Recruiting
Good Samaritan Hospital
Cincinnati, Ohio, United States
Kim Brady, MD
Recruiting
Greater Cincinnati Medical Center
Cincinnati, Ohio, United States
David Lewis, MD
Recruiting
Oregon Health & Science University
Portland, Oregon, United States
Leonardo Pereira, MD
Recruiting
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States
Jason Baxter, MD
Recruiting
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Hyagriv Simah, MD
Recruiting
Umcg Dept of Ob/gyn
Greenville, South Carolina, United States
Kenneth Trofatter, MD
Recruiting
Swedish Medical Center
Seattle, Washington, United States
David Luthy, MD
Recruiting
University of Washington Medical Center
Seattle, Washington, United States
Withdrawn

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2008
Primary completion: 30 Sept 2010
Completion: 30 Sept 2010
Last update posted: 21 Jul 2010
Registered enrollment: 900
Registry id: NCT00700219

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.