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

Part of paid clinical trials in San Diego, California.

Sponsor
RTI International
Study ID
NCT07745101
Status
Not Yet Recruiting

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Conditions

  • Stillbirth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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)

Key Dates

First listed
Aug 4, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
7,000 participants (estimated)

Arms

  • Arm: Early Pregnancy Cohort
    * 18 years or older * 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
  • Arm: Late Pregnancy Cohort
    * 18 years or older * Gestational age at enrollment: greater than or equal to 28.0 weeks gestational age * Clinical indications of risk (FGR \<10th percentile or report of decreased fetal movement) * Pregnant individual receiving care at participating clinical sites with intent of delivering at study hospital * Consent to participate in study procedures through 6 weeks postpartum

Primary Outcome Measure

The primary outcome is a composite outcome of stillbirth or severe placental dysfunction, defined as the occurrence of birth at or beyond 20.0 weeks of gestation. [ Time Frame: 7 days post delivery ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California Center for Stillbirth PreventionSan DiegoCalifornia92093
Mana Parast, MD, PhD
[email protected]
858-534-8631
Mana Parast, MD, PhD (PRINCIPAL_INVESTIGATOR)
The Collaborative Action for Research to End Stillbirth (CARES) Research Center at Columbia UniversityNew YorkNew York10027
Uma Reddy, MD, MPH
[email protected]
240-401-3605
Uma Reddy, MD, MPH (PRINCIPAL_INVESTIGATOR)
Xiao Xu, PhD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Karen Gibbins, MD, MSCI
[email protected]
503-494-2101
Karen Gibbins, MD, MSCI (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Robert Silver, MD
[email protected]
801-581-8425
Robert Silver, MD (PRINCIPAL_INVESTIGATOR)
Old Dominion UniversityNorfolkVirginia23529
George Saade, MD
[email protected]
757-446-5257

Find similar trials in San Diego, CA

By research site
University of California Center for Stillbirth Prevention· San Diego, CAThe Collaborative Action for Research to End Stillbirth (CARES) Research Center at Columbia University· New York, NYOregon Health & Science University· Portland, ORUniversity of Utah· Salt Lake City, UTOld Dominion University· Norfolk, VA

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