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Hydrops: Diagnosing & Redefining Outcomes With Precision Study

NCT03412760 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-04-17

No results posted yet for this study

Summary

This is a national, prospective study designed to investigate the genetic etiologies of non-immune hydrops fetalis (NIHF) and other birth defects. At least half of prenatally diagnosed NIHF cases remain of unknown etiology after standard work up, and a substantial proportion of other birth defects remain of unknown etiology as well. The investigators are performing exome sequencing (ES) for the affected fetus or neonate in unexplained cases, as well as enrolling cases with a genetic explanation to represent the full spectrum of diseases underlying NIHF and other birth defects.

Conditions

  • Hydrops Fetalis
  • Birth Defect
  • Fetal Anomaly

Interventions

DIAGNOSTIC_TEST

Exome sequencing

Expansive genetic test performed for affected fetus or neonate.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    collaborator NIH

  • Fetal Health Foundation

    collaborator UNKNOWN

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Teresa Sparks, MD, MAS · University of California, San Francisco

  • Mary Norton, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2026-12-31
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03412760 on ClinicalTrials.gov