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

ConditionStillbirth
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRTI International

About this trial

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)

Eligibility criteria

Qualifiers

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

18 years or older

Disqualifiers

Evidence of fetal genetic anomaly or major structural malformation

Known fetal aneuploidy based on chorionic villus sampling

Positive cell-free fetal DNA screening for aneuploidy

Multifetal gestation

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

7,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators

RTI International

Lead sponsor

Old Dominion University

Collaborator

University of Utah

Collaborator

Columbia University

Collaborator

University of California, San Diego

Collaborator

Oregon Health and Science University

Collaborator

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

Collaborator