Clinical trial NCT02920346: Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor
Official title: Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjogren's Syndrome
Neonatal Systemic Lupus Erythematosus
Fetal Heart Block Complete
Keywords: Neonatal Systemic lupus erythematosus
Sjogren's syndrome
Fetal Atrioventricular Block
Fetal Heart Block
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
name: Stollery Children's Hospital
name: The Hospital for Sick Children
name: New York Presbyterian Hospital
name: University of California, San Francisco
name: Children's Hospital of Philadelphia
name: Karolinska Institutet
name: St. Justine's Hospital
name: Johns Hopkins All Children's Hospital
name: Sanford Health
name: Seattle Children's Hospital
name: Eastern Virginia Medical School
name: Children's Hospital Colorado
name: University of Minnesota
name: The University of Texas Health Science Center, Houston
name: Phoenix Children's Hospital
First posted: 2016-09-30
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Development of Fetal AV (atrio-ventricular) heart block
timeFrame: Date of randomization until the date of first documented progression, assessed up to 41 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Bettina F Cuneo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.