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

Completed

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

• Registration Number: NCT02920346
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Primary Completion: 2020-06-16
• Study Completion: 2020-06-16
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of Fetal AV (atrio-ventricular) heart block	Date of randomization until the date of first documented progression, assessed up to 41 weeks.	Development of fetal AV heart block will be determined by the principal investigator's analysis of the fetal echocardiogram.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States