Recruiting

Observational Study

Sponsor:

ProteoGenix, Inc.

Code:

NCT00700219

Conditions

Intra-amniotic Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Intra-amniotic Infection

Study ID

NCT00700219

Start date

Jun, 2008

Status verified date

Jul, 2010

Completion date

Sep, 2010

Anticipated

Primary completion date

Sep, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject is greater than or equal to 18 years of age
  • Subject has singleton gestation
  • Subject has fetus with gestational age greater than or equal to 22 0/7 weeks and less than or equal to 36 6/7 weeks
  • Subject has documented intact amniotic membranes
  • Subject's care provider plans to or has performed an amniocentesis procedure
  • Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (greater than or equal to four per hour, or if less than 26 weeks gestation, cramping or backache) and one or more of the following:

1. Progressive cervical change with cervical dilation of greater than or equal to 2 cm
2. Effacement of greater than or equal to 50%
3. Cervical length of less than or equal to 30 mm via transvaginal ultrasound
4. Positive fetal fibronectin test

Exclusion Criteria:

  • Subject has documented ruptured amniotic membranes
  • Subject has fetus with major fetal anomaly or chromosomal aneuploidy
  • Subject has medical indication for preterm birth (e.g. pre-eclampsia)
  • Subject is unable to provide written informed consent

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Women presenting in preterm labor with intact amniotic membranes

Primary outcome measure

  • Performance of immunoassay panel to detect intra-amniotic infection in target population. [ Time Frame: Presentation to delivery ]

Central Contacts and Locations

Central contacts

Desiree Hollemon, MSN, MPH

503-748-4067hollemon@proteogenix.com

Durlin Hickok, MD

503-748-4067hickok@proteogenix.com

Locations

Banner Desert Memorial Medical Center

Recruiting

Mesa, Arizona, United States, 85202

Contacts

Melissa Ingersoll, RN

602-239-3632melissa_ingersoll@pediatrix.com

Principal Investigator:

William Clewell, MD

Banner Good Samaritan Hospital

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Melissa Ingersoll, BSN

602-239-3632melissa_ingersoll@pediatrix.com

Principal Investigator:

William Clewell, MD

Tucson Medical Center

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Diane Mercer, BSN

520-881-9662mercer.diane@gmail.com

Principal Investigator:

Hugh Miller, MD

Long Beach Memorial Hospital

Recruiting

Long Beach, California, United States, 90801

Contacts

Christine Preslicka, BSN

562-933-2755cpreslicka@memorialcare.org

Principal Investigator:

Michael Nageotte, MD

Good Samaritan Hospital

Recruiting

San Jose, California, United States, 95008

Contacts

Kimberly Mallory, BSN

408-761-3565kimberly_mallory@pediatrix.com

Principal Investigator:

Andrew Combs, MD, PhD

Presbyterian St. Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80218

Contacts

Jeri Lech, BSN

303-523-0719jeri_lech@pediatrix.com

Principal Investigator:

Richard Porecco, MD

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Cathy McCormick, RN

317-630-6572catmccor@iupui.edu

Principal Investigator:

David Haas, MD

Norton Downtown

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Chrisitina Motsinger

502-629-2433christina.motsinger@nortonhealthcare.org

Principal Investigator:

Helen How, MD

St. Louis University School of Medicine

Recruiting

St. Louis, Missouri, United States, 63117

Contacts

Brittaney Whisenand, RN

314-977-2161bwhisena@slu.edu

Margot Hirling

314-977-7482mhirling@slu.edu

Principal Investigator:

Erol Amon, MD

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Clare Hansen

856-968-7547hansen-clare@cooperhealth.edu

Principal Investigator:

Thomas Westover, MD

Mount Sinai School of Medicine

Recruiting

NYC, New York, United States, 10029

Contacts

Nokmenee Chhun

212-241-6551nok.chhun@mssm.edu

Principal Investigator:

Keith Eddleman, MD

Carolinas Medical Center /Dept. OB/GYN

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Nicki Dimaria, RN

704-355-8834nicki.dimaria@carolinashealthcare.org

Principal Investigator:

Albert Franco, MD

Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Peggy Walsh

513-862-2707peggy_walsh@trihealth.com

Principal Investigator:

Kim Brady, MD

Greater Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Chris DeAmond

513-584-4130christine.deamond@uc.edu

Principal Investigator:

David Lewis, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Monica Rincon, BSN

503-494-8748rincon@ohsu.edu

Principal Investigator:

Leonardo Pereira, MD

Thomas Jefferson University Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Susan Weiner, MSN

215-955-9243susan.weiner@jefferson.edu

Principal Investigator:

Jason Baxter, MD

University of Pittsburgh, Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Margaret Cotroneo, BSN

412-641-4055

Principal Investigator:

Hyagriv Simah, MD

UMCG Dept of OB/GYN

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Chrystal Prater, RN

864-455-4872cprater@ghs.org

Principal Investigator:

Kenneth Trofatter, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Theresa Murray, BSN

206-215-3541theresa_murray@pediatrix.com

Principal Investigator:

David Luthy, MD

More Information

Sponsor

ProteoGenix, Inc.

Last update posted

Jul 21, 2010

Last verified

Jul, 2010

Keywords

  • Preterm Labor
  • Preterm Birth
  • Intra-amniotic Infection
  • Pregnancy
  • Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ProteoGenix, Inc. on 2010-07-21.