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

NCT07745101 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 7000

Last updated 2026-08-04

No results posted yet for this study

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)

Conditions

Sponsors & Collaborators

  • Old Dominion University

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • RTI International

    lead OTHER

Principal Investigators

  • Elizabeth McClure, PhD · RTI International

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-07-31
Completion
2030-07-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745101 on ClinicalTrials.gov