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Completed

NCT Number: NCT02920346

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

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.

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Key information

Conditions

Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Fetal Heart Block Complete Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Neonatal Systemic Lupus Erythematosus Rheumatic Diseases Salivary Gland Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of Fetal AV (atrio-ventricular) heart block

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2016
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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