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

July 19, 2010 updated by: ProteoGenix, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intra-amniotic Infection

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.

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Women presenting in preterm labor with intact amniotic membranes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance of immunoassay panel to detect intra-amniotic infection in target population. Time Frame: Presentation to delivery	Presentation to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProteoGenix, Inc.

Collaborators

Obstetrix Medical Group

Investigators

Principal Investigator: Andrew Combs, MD, PhD, Obstetrix Medical Group of California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Combs CA, Garite TJ, Lapidus JA, Lapointe JP, Gravett M, Rael J, Amon E, Baxter JK, Brady K, Clewell W, Eddleman KA, Fortunato S, Franco A, Haas DM, Heyborne K, Hickok DE, How HY, Luthy D, Miller H, Nageotte M, Pereira L, Porreco R, Robilio PA, Simhan H, Sullivan SA, Trofatter K, Westover T; Obstetrix Collaborative Research Network. Detection of microbial invasion of the amniotic cavity by analysis of cervicovaginal proteins in women with preterm labor and intact membranes. Am J Obstet Gynecol. 2015 Apr;212(4):482.e1-482.e12. doi: 10.1016/j.ajog.2015.02.007. Epub 2015 Feb 14.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2010

Last Update Submitted That Met QC Criteria

July 19, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PGX01-OBX0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.