Intra-amniotic Infection Clinical Trial
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
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04831086 -
To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis
|
Phase 3 | |
| Withdrawn |
NCT03168178 -
Intrapartum Fever: Antibiotics Versus no Treatment
|
Phase 4 | |
| Completed |
NCT00701350 -
Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes
|
N/A |