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

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ClinicalTrials.gov Identifier: NCT02920346
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : December 27, 2018
Sponsor:
Collaborators:
Children's Research Institute
Stollery Children's Hospital
The Hospital for Sick Children
New York Presbyterian Hospital
University of California, San Francisco
Children's Hospital of Philadelphia
Karolinska Institutet
St. Justine's Hospital
Johns Hopkins All Children's Hospital
Sanford Health
Seattle Children's Hospital
Eastern Virginia Medical School
Children's Hospital Colorado
University of Minnesota - Clinical and Translational Science Institute
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
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).

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor
Study Start Date : April 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020





Primary Outcome Measures :
  1. Development of Fetal AV (atrio-ventricular) heart block [ Time Frame: Date of randomization until the date of first documented progression, assessed up to 41 weeks. ]
    Development of fetal AV heart block will be determined by the principal investigator's analysis of the fetal echocardiogram.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920346


Contacts
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Contact: Bettina F Cuneo, MD (720)777-6820 bettina.cuneo@childrenscolorado.org
Contact: Halley J Isberg, BA (720) 777-9514 halley.isberg@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Halley J Isberg, BA    720-777-9514    Halley.Isberg@childrenscolorado.org   
Contact: Megan A Brocato, BA    720-777-8864    megan.brocato@childrenscolorado.org   
Principal Investigator: Bettina F Cuneo, MD         
Sub-Investigator: Lisa W. Howley, MD         
Sponsors and Collaborators
University of Colorado, Denver
Children's Research Institute
Stollery Children's Hospital
The Hospital for Sick Children
New York Presbyterian Hospital
University of California, San Francisco
Children's Hospital of Philadelphia
Karolinska Institutet
St. Justine's Hospital
Johns Hopkins All Children's Hospital
Sanford Health
Seattle Children's Hospital
Eastern Virginia Medical School
Children's Hospital Colorado
University of Minnesota - Clinical and Translational Science Institute
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Bettina F Cuneo, MD University of Colorado, Denver

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02920346     History of Changes
Other Study ID Numbers: 13-1879
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Neonatal Systemic lupus erythematosus
Sjogren's syndrome
Fetal Atrioventricular Block
Fetal Heart Block
Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Heart Block
Lupus Erythematosus, Systemic
Syndrome
Disease
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease