Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor

NCT02920346 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2021-06-23

No results posted yet for this study

Summary

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

Conditions

  • Sjogren's Syndrome
  • Neonatal Systemic Lupus Erythematosus
  • Fetal Heart Block Complete

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER
  • Stollery Children's Hospital

    collaborator OTHER
  • The Hospital for Sick Children

    collaborator OTHER
  • New York Presbyterian Hospital

    collaborator OTHER
  • University of California, San Francisco

    collaborator OTHER
  • Children's Hospital of Philadelphia

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • St. Justine's Hospital

    collaborator OTHER
  • Johns Hopkins All Children's Hospital

    collaborator OTHER
  • Sanford Health

    collaborator OTHER
  • Seattle Children's Hospital

    collaborator OTHER
  • Eastern Virginia Medical School

    collaborator OTHER
  • Children's Hospital Colorado

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • The University of Texas Health Science Center, Houston

    collaborator OTHER
  • Phoenix Children's Hospital

    collaborator OTHER
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Bettina F Cuneo, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-06-16
Completion
2020-06-16

Countries

  • United States

Study Locations

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Entities

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 NCT02920346 on ClinicalTrials.gov