An observational study in Intra-amniotic Infection, sponsored by ProteoGenix, Inc.. Status unknown at 21 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-21.
Sponsored by ProteoGenix, Inc. · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 900 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →ProteoGenix, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes
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:
Exclusion Criteria:
Women presenting in preterm labor with intact amniotic membranes
Performance of immunoassay panel to detect intra-amniotic infection in target population.
Time frame: Presentation to delivery
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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ProteoGenix, Inc.