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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by ProteoGenix, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Obstetrix Medical Group
Information provided by:
ProteoGenix, Inc.
ClinicalTrials.gov Identifier:
NCT00700219
First received: June 13, 2008
Last updated: July 19, 2010
Last verified: July 2010
  Purpose

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.


Condition
Intra-amniotic Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Non-invasive Test to Detect Intra-amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and and Intact Amniotic Membranes

Further study details as provided by ProteoGenix, Inc.:

Primary Outcome Measures:
  • Performance of immunoassay panel to detect intra-amniotic infection in target population. [ Time Frame: Presentation to delivery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Maternal Urine, Placental and Umbilical Cord Tissues


Estimated Enrollment: 900
Study Start Date: June 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women presenting in preterm labor with intact amniotic membranes

Detailed Description:

Intra-amniotic infection (IAI) is an acute bacterial infection of the amniotic fluid and intrauterine contents during pregnancy and occurs in 4% to 10% of all deliveries (Newton, ER., 1993. Newton, ER, et al., 1989. Soper, DE, et al., 1989). IAI is an important cause of maternal and neonatal morbidity. Identifying and appropriately treating women with IAI is, therefore, a major obstetrical challenge.

Intrauterine infection may occur early in pregnancy and remain undetected for a prolonged period, thus exposing the fetus to the effects of infection/inflammation for a considerable period. Ideally, an early diagnosis of IAI is important to allow timely treatment and intervention. Unfortunately, the early diagnosis is difficult because the clinical signs and symptoms of IAI may occur late in the course of the infection and are neither sensitive nor specific. Therefore, to avoid a delay in diagnosis a high degree of suspicion and the appropriate use of adjunctive laboratory tests are warranted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700219

Contacts
Contact: Desiree Hollemon, MSN, MPH 503-748-4067 hollemon@proteogenix.com
Contact: Durlin Hickok, MD 503-748-4067 hickok@proteogenix.com

Locations
United States, Arizona
Banner Desert Memorial Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Melissa Ingersoll, RN    602-239-3632    melissa_ingersoll@pediatrix.com   
Contact: Amanda Osbourne, BSN         
Principal Investigator: William Clewell, MD         
Banner Good Samaritan Hospital Recruiting
Phoenix, Arizona, United States, 85006
Contact: Melissa Ingersoll, BSN    602-239-3632    melissa_ingersoll@pediatrix.com   
Contact: Amanda Osbourne, BSN         
Principal Investigator: William Clewell, MD         
Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85712
Contact: Diane Mercer, BSN    520-881-9662    mercer.diane@gmail.com   
Principal Investigator: Hugh Miller, MD         
United States, California
Long Beach Memorial Hospital Recruiting
Long Beach, California, United States, 90801
Contact: Christine Preslicka, BSN    562-933-2755    cpreslicka@memorialcare.org   
Contact: , BSN         
Principal Investigator: Michael Nageotte, MD         
Good Samaritan Hospital Recruiting
San Jose, California, United States, 95008
Contact: Kimberly Mallory, BSN    408-761-3565    kimberly_mallory@pediatrix.com   
Contact: Tammy Meyer, BSN         
Principal Investigator: Andrew Combs, MD, PhD         
United States, Colorado
Presbyterian St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jeri Lech, BSN    303-523-0719    jeri_lech@pediatrix.com   
Contact: Julie Rael, BSN         
Principal Investigator: Richard Porecco, MD         
Swedish Medical Center Withdrawn
Englewood, Colorado, United States, 80110
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Cathy McCormick, RN    317-630-6572    catmccor@iupui.edu   
Principal Investigator: David Haas, MD         
United States, Kentucky
Norton Downtown Recruiting
Louisville, Kentucky, United States, 40202
Contact: Chrisitina Motsinger    502-629-2433    christina.motsinger@nortonhealthcare.org   
Principal Investigator: Helen How, MD         
United States, Missouri
St. Louis University School of Medicine Recruiting
St. Louis, Missouri, United States, 63117
Contact: Brittaney Whisenand, RN    314-977-2161    bwhisena@slu.edu   
Contact: Margot Hirling    314-977-7482    mhirling@slu.edu   
Principal Investigator: Erol Amon, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Clare Hansen    856-968-7547    hansen-clare@cooperhealth.edu   
Principal Investigator: Thomas Westover, MD         
United States, New York
Mount Sinai School of Medicine Recruiting
NYC, New York, United States, 10029
Contact: Nokmenee Chhun    212-241-6551    nok.chhun@mssm.edu   
Principal Investigator: Keith Eddleman, MD         
United States, North Carolina
Carolinas Medical Center /Dept. OB/GYN Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Nicki Dimaria, RN    704-355-8834    nicki.dimaria@carolinashealthcare.org   
Principal Investigator: Albert Franco, MD         
United States, Ohio
Greater Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Chris DeAmond    513-584-4130    christine.deamond@uc.edu   
Principal Investigator: David Lewis, MD         
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Peggy Walsh    513-862-2707    peggy_walsh@trihealth.com   
Principal Investigator: Kim Brady, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Monica Rincon, BSN    503-494-8748    rincon@ohsu.edu   
Contact: , BS         
Principal Investigator: Leonardo Pereira, MD         
United States, Pennsylvania
Thomas Jefferson University Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Susan Weiner, MSN    215-955-9243    susan.weiner@jefferson.edu   
Principal Investigator: Jason Baxter, MD         
University of Pittsburgh, Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Margaret Cotroneo, BSN    412-641-4055      
Contact: Terri Kamon, BSN         
Principal Investigator: Hyagriv Simah, MD         
United States, South Carolina
UMCG Dept of OB/GYN Recruiting
Greenville, South Carolina, United States, 29605
Contact: Chrystal Prater, RN    864-455-4872    cprater@ghs.org   
Principal Investigator: Kenneth Trofatter, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Theresa Murray, BSN    206-215-3541    theresa_murray@pediatrix.com   
Principal Investigator: David Luthy, MD         
University of Washington Medical Center Withdrawn
Seattle, Washington, United States, 98195
Sponsors and Collaborators
ProteoGenix, Inc.
Obstetrix Medical Group
Investigators
Principal Investigator: Andrew Combs, MD, PhD Obstetrix Medical Group of California
  More Information

No publications provided

Responsible Party: Durlin Hickok, MD, MPH, ProteoGenix, Inc.
ClinicalTrials.gov Identifier: NCT00700219     History of Changes
Other Study ID Numbers: PGX01-OBX0006
Study First Received: June 13, 2008
Last Updated: July 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by ProteoGenix, Inc.:
Preterm Labor
Preterm Birth
Intra-amniotic Infection
Pregnancy
Women

Additional relevant MeSH terms:
Infection
Communicable Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 22, 2014