Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
NCT ID: NCT00700219
Last Updated: 2010-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
900 participants
OBSERVATIONAL
2008-06-30
2010-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
Women presenting in preterm labor with intact amniotic membranes
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Obstetrix Medical Group
INDUSTRY
ProteoGenix, Inc.
INDUSTRY
Responsible Party
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ProteoGenix, Inc.
Principal Investigators
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Andrew Combs, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Obstetrix Medical Group of California
Locations
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Banner Desert Memorial Medical Center
Mesa, Arizona, United States
Banner Good Samaritan Hospital
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Long Beach Memorial Hospital
Long Beach, California, United States
Good Samaritan Hospital
San Jose, California, United States
Presbyterian St. Luke's Medical Center
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Norton Downtown
Louisville, Kentucky, United States
St. Louis University School of Medicine
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Carolinas Medical Center /Dept. OB/GYN
Charlotte, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Greater Cincinnati Medical Center
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
UMCG Dept of OB/GYN
Greenville, South Carolina, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Amanda Osbourne, BSN
Role: backup
Amanda Osbourne, BSN
Role: backup
BSN
Role: backup
Tammy Meyer, BSN
Role: backup
Julie Rael, BSN
Role: backup
BS
Role: backup
Margaret Cotroneo, BSN
Role: primary
Terri Kamon, BSN
Role: backup
References
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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.
Other Identifiers
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PGX01-OBX0006
Identifier Type: -
Identifier Source: org_study_id
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