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 range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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