NCT02920346

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2020

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

6.3 years

First QC Date

August 3, 2016

Last Update Submit

June 21, 2021

Conditions

Sjogren's SyndromeNeonatal Systemic Lupus ErythematosusFetal Heart Block Complete

Keywords

Neonatal Systemic lupus erythematosusSjogren's syndromeFetal Atrioventricular BlockFetal Heart Block

Outcome Measures

Primary Outcomes (1)

  • Development of Fetal AV (atrio-ventricular) heart block

    Development of fetal AV heart block will be determined by the principal investigator's analysis of the fetal echocardiogram.

    Date of randomization until the date of first documented progression, assessed up to 41 weeks.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will include all pregnant women with positive SSA or SSA and SSB antibodies between the gestational ages of 16-19 weeks with no signs of antibody-mediated fetal cardiac disease on pre-enrollment fetal echocardiogram. Subjects who are more than 19 weeks gestation will not be included. Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included.

You may qualify if:

  • Pregnant women with positive SSA or SSA and SSB antibodies
  • Gestational age (GA) between 16 and 19 weeks
  • No signs of antibody-mediated fetal cardiac disease on pre-enrollment echo

You may not qualify if:

  • Subjects who are more than 19 weeks gestation
  • Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • Cuneo BF, Strasburger JF, Niksch A, Ovadia M, Wakai RT. An expanded phenotype of maternal SSA/SSB antibody-associated fetal cardiac disease. J Matern Fetal Neonatal Med. 2009 Mar;22(3):233-8. doi: 10.1080/14767050802488220.

    PMID: 19330707BACKGROUND

  • Cuneo BF, Lee M, Roberson D, Niksch A, Ovadia M, Parilla BV, Benson DW. A management strategy for fetal immune-mediated atrioventricular block. J Matern Fetal Neonatal Med. 2010 Dec;23(12):1400-5. doi: 10.3109/14767051003728237. Epub 2010 Apr 12.

    PMID: 20384469BACKGROUND

  • Cuneo BF, Sonesson SE, Levasseur S, Moon-Grady AJ, Krishnan A, Donofrio MT, Raboisson MJ, Hornberger LK, Van Eerden P, Sinkovskaya E, Abuhamad A, Arya B, Szwast A, Gardiner H, Jacobs K, Freire G, Howley L, Lam A, Kaizer AM, Benson DW, Jaeggi E. Home Monitoring for Fetal Heart Rhythm During Anti-Ro Pregnancies. J Am Coll Cardiol. 2018 Oct 16;72(16):1940-1951. doi: 10.1016/j.jacc.2018.07.076.

    PMID: 30309472DERIVED

Related Links

MeSH Terms

Conditions

Sjogren's SyndromeNeonatal Systemic lupus erythematosus

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bettina F Cuneo, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

September 30, 2016

Study Start

March 1, 2014

Primary Completion

June 16, 2020

Study Completion

June 16, 2020

Last Updated

June 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)