Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
- Conditions
- Intra-amniotic Infection
- Registration Number
- NCT00700219
- Lead Sponsor
- ProteoGenix, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 900
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of immunoassay panel to detect intra-amniotic infection in target population. Presentation to delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Banner Desert Memorial Medical Center
🇺🇸Mesa, Arizona, United States
Long Beach Memorial Hospital
🇺🇸Long Beach, California, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Banner Good Samaritan Hospital
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Thomas Jefferson University Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh, Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Norton Downtown
🇺🇸Louisville, Kentucky, United States
Mount Sinai School of Medicine
🇺🇸NYC, New York, United States
UMCG Dept of OB/GYN
🇺🇸Greenville, South Carolina, United States
St. Louis University School of Medicine
🇺🇸St. Louis, Missouri, United States
Greater Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Presbyterian St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Carolinas Medical Center /Dept. OB/GYN
🇺🇸Charlotte, North Carolina, United States