Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
Status unconfirmed
Conditions studied: Intra-amniotic Infection
In brief
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.
Key facts
- Study ID
- NCT00700219
- Run by
- ProteoGenix, Inc.
- People needed
- 900
- Starts
- 2008-06-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2010-07-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Banner Desert Memorial Medical Center — Mesa, Arizona, United States (enrolling)
- Banner Good Samaritan Hospital — Phoenix, Arizona, United States (enrolling)
- Tucson Medical Center — Tucson, Arizona, United States (enrolling)
- Long Beach Memorial Hospital — Long Beach, California, United States (enrolling)
- Good Samaritan Hospital — San Jose, California, United States (enrolling)
- Presbyterian St. Luke's Medical Center — Denver, Colorado, United States (enrolling)
- UMCG Dept of OB/GYN — Greenville, South Carolina, United States (enrolling)
- Swedish Medical Center — Seattle, Washington, United States (enrolling)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
- Norton Downtown — Louisville, Kentucky, United States (enrolling)
- St. Louis University School of Medicine — St Louis, Missouri, United States (enrolling)
- Cooper University Hospital — Camden, New Jersey, United States (enrolling)
- Mount Sinai School of Medicine — New York, New York, United States (enrolling)
- Carolinas Medical Center /Dept. OB/GYN — Charlotte, North Carolina, United States (enrolling)
- Good Samaritan Hospital — Cincinnati, Ohio, United States (enrolling)
- Greater Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Thomas Jefferson University Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
- University of Pittsburgh, Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- Swedish Medical Center — Englewood, Colorado, United States
- University of Washington Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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