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

Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor

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.

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome; Neonatal Systemic Lupus Erythematosus; Fetal Heart Block Complete

Detailed Description

The study will enroll mothers during week 16-19 of gestation and will ask the mothers to use a hand-held Doppler monitor to listen to the baby's heart rate and rhythm twice daily from about week 16 to week 26 of the pregnancy. Pregnant mothers will be asked to keep a log of the heart rates and will undergo a fetal echocardiogram every 2 weeks during their study participation. In addition to these procedures, the study team will collect the mother's medical and obstetrical histories. Should irregular heart rhythms be detected at home, the mother will contact the investigator to be evaluated. After the baby is delivered, the study team will collect information about the baby's birth and heart rhythm evaluation (electrocardiogram).

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: The Hospital for Sick Children; Karolinska Institutet; The University of Texas Health Science Center, Houston; Children's Hospital of Philadelphia; Children's Hospital Colorado; Seattle Children's Hospital; University of California, San Francisco; University of Minnesota; Eastern Virginia Medical School; New York Presbyterian Hospital; Children's National Research Institute; Stollery Children's Hospital; St. Justine's Hospital; Phoenix Children's Hospital; Johns Hopkins All Children's Hospital; Sanford Health
• Investigators: Principal Investigator: Bettina F Cuneo, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: J Am Coll Cardiol. 2019 Jan 8;73(1):120.

Helpful Links

• study website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): June 16, 2020
• Study Completion (Actual): June 16, 2020

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Sjogren's syndrome; Neonatal Systemic lupus erythematosus; Fetal Atrioventricular Block; Fetal Heart Block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Lupus Erythematosus, Systemic; Heart Block; Sjogren's Syndrome
• Other Study ID Numbers: 13-1879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No