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Research On Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)

Study acronym: ROADMAPS
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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)
Trial Details
NCT Number NCT07745101
Lead Sponsor RTI International
Collaborators: Old Dominion University, University of Utah, Columbia University, University of California, San Diego, Oregon Health and Science University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Stillbirth
Related terms Fetal Growth Retardation, Stillbirth
Enrollment 7,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov