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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
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 Design

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Study Type :	Observational
Estimated Enrollment :	900 participants
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
Study Start Date :	June 2008
Estimated Primary Completion Date :	September 2010
Estimated Study Completion Date :	September 2010

Groups and Cohorts

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

Outcome Measures

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Primary Outcome Measures :

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

Biospecimen Retention:   Samples Without DNA

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Good Samaritan Hospital	Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Peggy Walsh 513-862-2707 peggy_walsh@trihealth.com
Principal Investigator: Kim Brady, MD
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
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Durlin Hickok, MD, MPH, ProteoGenix, Inc.
ClinicalTrials.gov Identifier:	NCT00700219 History of Changes
Other Study ID Numbers:	PGX01-OBX0006
First Posted:	June 18, 2008
Last Update Posted:	July 21, 2010
Last Verified:	July 2010

Keywords provided by ProteoGenix, Inc.:

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

Additional relevant MeSH terms:

Infection; Communicable Diseases; Premature Birth	Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications