Fetal Heart Block Complete, Neonatal Systemic Lupus Erythematosus, Sjogren's Syndrome
Conditions
Keywords
Neonatal Systemic lupus erythematosus, Sjogren's syndrome, Fetal Atrioventricular Block, Fetal Heart Block
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.
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).
Interventions
None listed
Sponsors
Children's National 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
The University of Texas Health Science Center, Houston
Phoenix Children's Hospital
University of Colorado, Denver
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Fetal AV (atrio-ventricular) heart block | 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. |
Countries
United States
Outcome results
None listed