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|
Recruitment Status : Unknown
Verified July 2010 by ProteoGenix, Inc..
Recruitment status was: Recruiting
First Posted : June 18, 2008
Last Update Posted : July 21, 2010
|Condition or disease|
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|
|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|
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 ]
Biospecimen Retention: Samples Without DNA
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
|Contact: Desiree Hollemon, MSN, MPHfirstname.lastname@example.org|
|Contact: Durlin Hickok, MDemail@example.com|
|Principal Investigator:||Andrew Combs, MD, PhD||Obstetrix Medical Group of California|