About this trial
The primary objective of the Stillbirth Research Consortium (SBRC) longitudinal cohort study is to develop and evaluate a robust multivariable prediction model to identify pregnancies at \<14 weeks gestation that are at increased risk of stillbirth or fetal growth restriction (FGR), often reflecting underlying placental dysfunction.
Secondary objectives include:
* To evaluate placental pathology among cases and selected controls using standardized Amsterdam criteria. * To identify key aspects of perinatal nutrition contributing to placental dysfunction * To determine relationships between maternal biomarkers, placental pathology and energetics, with the goal of identifying biomarkers predictive of placental dysfunction * To develop a risk stratification model for pregnancies complicated by decreased fetal movements (DFM)
Eligibility criteria
Qualifiers
Gestational age at enrollment: Between 12.0 and 13.6 weeks of gestation
Pregnant individuals receiving care at participating clinical sites with intent of delivering at study hospital
Consent to participate in study procedures through 6 weeks postpartum
18 years or older
Disqualifiers
Evidence of fetal genetic anomaly or major structural malformation
Known fetal aneuploidy based on chorionic villus sampling
Positive cell-free fetal DNA screening for aneuploidy
Multifetal gestation
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
RTI International
Lead sponsor
Old Dominion University
Collaborator
University of Utah
Collaborator
Columbia University
Collaborator
University of California, San Diego
Collaborator
Oregon Health and Science University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator