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NCT07745101

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

Sponsor: RTI International

View on ClinicalTrials.gov

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)

Official title: NICHD Stillbirth Research Consortium: Research on Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

7000

Start Date

2026-08-01

Completion Date

2030-07-31

Last Updated

2026-08-04

Healthy Volunteers

Yes

Conditions

Locations (5)

University of California Center for Stillbirth Prevention

San Diego, California, United States

The Collaborative Action for Research to End Stillbirth (CARES) Research Center at Columbia University

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Utah

Salt Lake City, Utah, United States

Old Dominion University

Norfolk, Virginia, United States