Preterm Birth Clinical Trial
Official title:
Identification of Proteomic Markers of Intra-amniotic Infection (IAI) in Patients With Preterm Premature Rupture of Amniotic Membranes (PPROM)
The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)
Preterm premature rupture of the membranes (PPROM) prior to 37 weeks of gestation occurs in
approximately 3% of all pregnancies and is associated with one-third of all preterm births
(Mercer, 2003). While there are multiple possible etiologies of PPROM, intra-amniotic
infection has been implicated as a major contributor, especially at early gestational ages
where fetal and neonatal adverse sequelae are frequent (Yoon, et al. 2000). Micro-organisms
are recovered from the amniotic fluid obtained by trans-abdominal amniocentesis in 25-40% of
women at the time of presentation with PPROM (Simhan and Canavan 2005).
Significant risks to the fetus following PPROM include both complications related to
prematurity and to infection or inflammation (ACOG Practice Bulletin 2007). Complications
related to prematurity include respiratory distress, intraventricular hemorrhage, and
necrotizing enterocolitis. IAI, both clinically apparent and occult, is an important and
potentially preventable cause of cerebral white matter injury and cerebral palsy. Ideally,
an early diagnosis of IAI in the setting of PPROM is important to allow timely treatment and
intervention. Amniocentesis is successful from 40 - 72% of the time with PPROM (Garite,
1982, Blackwell and Berry, 1999). Despite the accuracy for determining infection and the
feasibility of amniocentesis, the vast majority of clinicians are reluctant and/or unwilling
to perform this procedure in this clinical setting (Capeless and Mead, (1987). There is
therefore a critical need for a noninvasive test to identify patients with IAI and PPROM.
Timely identification of these sub-clinically infected patients is critical in designing
rationale and efficacious treatment strategies that may reduce the fetal and neonatal
sequelae associated with PPROM.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04021654 -
What is the Future of Vulnerable New-borns
|