Status:
UNKNOWN
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
Lead Sponsor:
ProteoGenix, Inc.
Collaborating Sponsors:
Obstetrix Medical Group
Conditions:
Intra-amniotic Infection
Eligibility:
FEMALE
18+ years
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 w...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00700219
Start Date
June 1 2008
End Date
September 1 2010
Last Update
July 21 2010
Active Locations (21)
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1
Banner Desert Memorial Medical Center
Mesa, Arizona, United States, 85202
2
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
3
Tucson Medical Center
Tucson, Arizona, United States, 85712
4
Long Beach Memorial Hospital
Long Beach, California, United States, 90801