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NCT02920346 Clinical Trial

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

Sjogren's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02920346
Other study ID # 13-1879
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2014
Est. completion date June 16, 2020

Study information
Verified date June 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 700
Est. completion date June 16, 2020
Est. primary completion date June 16, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (17)
Lead Sponsor Collaborator
University of Colorado, Denver Children's Hospital Colorado, Children's Hospital of Philadelphia, Children's National Research Institute, Eastern Virginia Medical School, Johns Hopkins All Children's Hospital, Karolinska Institutet, New York Presbyterian Hospital, Phoenix Children's Hospital, Sanford Health, Seattle Children's Hospital, St. Justine's Hospital, Stollery Children's Hospital, The Hospital for Sick Children, The University of Texas Health Science Center, Houston, University of California, San Francisco, University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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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