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

Completed

Conditions studied: Sjogren's Syndrome, Neonatal Systemic Lupus Erythematosus, Fetal Heart Block Complete

In brief

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.

Key facts

Study ID

NCT02920346

Run by

University of Colorado, Denver

People needed

700

Starts

2014-03-01

Expected to finish

2020-06-16

Last updated by the study team

2021-06-23

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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