Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT02441335
The goal of this study is to examine how cellular dysfunction can lead to preterm birth. Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture of membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries (greater than 38 weeks) will be enrolled. Medical/obstetric history and pregnancy outcomes will be recorded. Maternal blood, urine and cervical cells (enrollment); cord blood and placental biopsy (delivery) will be collected.
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Notify Me18 year–45 year
Female
Observational
Philadelphia, Pennsylvania, 19104, United States
Despite improvements in prenatal care, preterm birth (PTB) remains a leading contributor to perinatal morbidity and mortality. Several genetic and environmental factors have been associated with spontaneous preterm birth, but the pathways by which these factors induce preterm delivery have not been defined. The March of Dimes CPR at the University of Pennsylvania was created to help elucidate the pathogenesis of preterm birth by bringing together a diverse team of investigators with expertise in preterm birth, cellular metabolism, genetics, mitochondrial functional analyses, genome, epigenome, and transcriptome profiling, integrated bioinformatics analyses, and microbiome research. The center will focus on addressing the interactions between bioenergetics, genetics, microbiome, abnormal cervical remodeling and placental dysfunction. Each one of these factors will be studied independently and in relation to the other factors. In order to study metabolic processes in relation to spontaneous PTB, a prospective case-control study will be performed. This study will involve women with singleton pregnancies with spontaneous preterm labor (PTL), preterm premature rupture of membranes (PPROM), and cervical insufficiency, between 20-0/7 and 36-6/7 weeks gestational age (cases), and women with term deliveries (38 to 41 weeks gestation, controls). The investigators will obtain information regarding the patients' pertinent past medical and obstetric histories, and the following specimens will be collected: maternal blood, maternal urine, and cervical epithelial cells at enrollment; and umbilical cord blood and placental biopsies at delivery. We will follow and record each of these patients' pregnancy outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Cases:
Inclusion criteria
Exclusion criteria
Controls:
Inclusion criteria
Exclusion criteria
Time frame: 5 years
The role of biogenetics in pregnancy and what are the perturbations in cell metabolism that lead to spontaneous preterm birth.
Time frame: 5 years
The interactions between the microbiome (oral, gut, cervicovaginal, and placental) and host metabolic function in pregnancy.
Time frame: 5 years
How the interactions between cell metabolism and the microbiome influence cervical remodeling and placental function leading to spontaneous preterm delivery.
Time frame: 5 years
How genetic and environmental factors influence the metabolic function of reproductive tissues leading to spontaneous preterm delivery.
University of Pennsylvania
Other
Acronym: CRIB
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