Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes (IAI)
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| ClinicalTrials.gov Identifier: NCT00700219 |
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Recruitment Status : Unknown
Verified July 2010 by ProteoGenix, Inc..
Recruitment status was: Recruiting
First Posted : June 18, 2008
Last Update Posted : July 21, 2010
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Sponsor:
ProteoGenix, Inc.
Collaborator:
Obstetrix Medical Group
Information provided by:
ProteoGenix, Inc.
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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 |
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| Intra-amniotic Infection |
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 |
| 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 |
| Group/Cohort |
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1
Women presenting in preterm labor with intact amniotic membranes
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Primary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| Last Update Posted: | July 21, 2010 |
| Last Verified: | July 2010 |
Keywords provided by ProteoGenix, Inc.:
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Preterm Labor Preterm Birth Intra-amniotic Infection Pregnancy Women |
Additional relevant MeSH terms:
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Infection Communicable Diseases Premature Birth |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |