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| Name | Class |
|---|---|
| Children's National Research Institute | OTHER |
| Stollery Children's Hospital | OTHER |
| The Hospital for Sick Children | OTHER |
| New York Presbyterian Hospital |
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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.
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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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bettina F Cuneo, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19330707 | Background | 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. | |
| 20384469 | Background | 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. |
| Label | URL |
|---|---|
| study website | View source |
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| OTHER |
| University of California, San Francisco | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Karolinska Institutet | OTHER |
| St. Justine's Hospital | OTHER |
| Johns Hopkins All Children's Hospital | OTHER |
| Sanford Health | OTHER |
| Seattle Children's Hospital | OTHER |
| Eastern Virginia Medical School | OTHER |
| Children's Hospital Colorado | OTHER |
| University of Minnesota | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Phoenix Children's Hospital | OTHER |
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| 30309472 | Derived | 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. |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| C536397 | Neonatal Systemic lupus erythematosus |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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