Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
IAI
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
1 other identifier
observational
900
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJuly 21, 2010
July 1, 2010
2.3 years
June 13, 2008
July 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance of immunoassay panel to detect intra-amniotic infection in target population.
Presentation to delivery
Study Arms (1)
1
Women presenting in preterm labor with intact amniotic membranes
Eligibility Criteria
Women presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes
You may qualify if:
- 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:
- Progressive cervical change with cervical dilation of greater than or equal to 2 cm
- Effacement of greater than or equal to 50%
- Cervical length of less than or equal to 30 mm via transvaginal ultrasound
- Positive fetal fibronectin test
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ProteoGenix, Inc.lead
- Obstetrix Medical Groupcollaborator
Study Sites (21)
Banner Desert Memorial Medical Center
Mesa, Arizona, 85202, United States
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
Long Beach Memorial Hospital
Long Beach, California, 90801, United States
Good Samaritan Hospital
San Jose, California, 95008, United States
Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Norton Downtown
Louisville, Kentucky, 40202, United States
St. Louis University School of Medicine
St Louis, Missouri, 63117, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Carolinas Medical Center /Dept. OB/GYN
Charlotte, North Carolina, 28203, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Greater Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UMCG Dept of OB/GYN
Greenville, South Carolina, 29605, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 25687566DERIVED
Biospecimen
Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Maternal Urine, Placental and Umbilical Cord Tissues
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Combs, MD, PhD
Obstetrix Medical Group of California
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 18, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
July 21, 2010
Record last verified: 2010-07