๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-12-05

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (NCT04301518)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Sera Prognostics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.

Who can join: Review the eligibility criteria below.

Location: UCSD โ€” San Diego, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Multimodal intervention strategy (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (18 Sites)

  • UCSD โ€” San Diego, California
  • Yale โ€” New Haven, Connecticut
  • Delaware/Christiana Care โ€” Newark, Delaware
  • Emerald Coast โ€” Panama City, Florida
  • University of Kentucky Healthcare โ€” Lexington, Kentucky
  • Ochsner โ€” New Orleans, Louisiana
  • LSU โ€” Shreveport, Louisiana
  • Boston Medical Center โ€” Boston, Massachusetts
  • Beaumont Hospital โ€” Royal Oak, Michigan
  • High Risk Pregnancy Center โ€” Las Vegas, Nevada
  • Mt Sinai โ€” New York, New York
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Ohio Health โ€” Columbus, Ohio
  • UTMB โ€” Galveston, Texas
  • University of Virginia โ€” Charlottesville, Virginia
  • Inova Health Care Services โ€” Falls Church, Virginia
  • VPFW โ€” Richmond, Virginia
  • MCW โ€” Milwaukee, Wisconsin

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—