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

Brief Title

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

Official Title

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

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 Type

Observational


Primary Outcome

Development of Fetal AV (atrio-ventricular) heart block


Condition

Sjogren's Syndrome



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

700

Start Date

March 2014

Completion Date

June 16, 2020

Primary Completion Date

June 16, 2020

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Bettina F Cuneo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02920346

Organization ID

13-1879


Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Collaborators

 Children's National Research Institute

Study Sponsor

Bettina F Cuneo, MD, Principal Investigator, University of Colorado, Denver


Verification Date

June 2021