CompletedNot Applicable

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

United States700 participantsStarted 2014-03

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Development of Fetal AV (atrio-ventricular) heart block

Timeframe: Date of randomization until the date of first documented progression, assessed up to 41 weeks.

Trial details

NCT IDNCT02920346

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-06-16

View on ClinicalTrials.gov More Sjogren's Syndrome trials