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

University of Colorado Denver (CU Denver)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT02920346

13-1879

Details and patient eligibility

About

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.

Full 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).

Enrollment: 700 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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