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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02920346

Collaborator

Children's National Research Institute (Other), Stollery Children's Hospital (Other), The Hospital for Sick Children (Other), New York Presbyterian Hospital (Other), University of California, San Francisco (Other), Children's Hospital of Philadelphia (Other), Karolinska Institutet (Other), St. Justine's Hospital (Other), Johns Hopkins All Children's Hospital (Other), Sanford Health (Other), Seattle Children's Hospital (Other), Eastern Virginia Medical School (Other), Children's Hospital Colorado (Other), University of Minnesota (Other), The University of Texas Health Science Center, Houston (Other), Phoenix Children's Hospital (Other)

700

Enrollment

Location

75.5

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome Neonatal Systemic Lupus Erythematosus Fetal Heart Block Complete

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 Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jun 16, 2020

Actual Study Completion Date :

Jun 16, 2020

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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