Clinical Trial

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

Study acronym: ROADMAPS
Not Yet Recruiting
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Summary
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 Stillbirth
Enrollment 7,000 participants
Start Date 2026-08-01
Primary Completion 2030-07-31 (estimated)
Study Completion 2030-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04