Sjogren's SyndromeNCT02920346
Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor
An observational study of Sjogren's Syndrome and Neonatal Systemic Lupus Erythematosus, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Sjogren's Syndrome, Neonatal Systemic Lupus Erythematosus, Fetal Heart Block Complete
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 16 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will include all pregnant women with positive SSA or SSA and SSB antibodies between the gestational ages of 16-19 weeks with no signs of antibody-mediated fetal cardiac disease on pre-enrollment fetal echocardiogram. Subjects who are more than 19 weeks gestation will not be included. Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Heart Sounds at Home: Prospective Maternal Surveillance of SSA 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.
Read the 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).
- Keywords
- Neonatal Systemic lupus erythematosus, Sjogren's syndrome, Fetal Atrioventricular Block, Fetal Heart Block
- Medical subject headings
- Sjogren's Syndrome, Neonatal Systemic lupus erythematosus
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Fetal AV (atrio-ventricular) heart block
Development of fetal AV heart block will be determined by the principal investigator's analysis of the fetal echocardiogram.
Measured: Date of randomization until the date of first documented progression, assessed up to 41 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startMar 2014
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute, Stollery Children's Hospital, The Hospital for Sick Children, New York Presbyterian Hospital, University of California, San Francisco, Children's Hospital of Philadelphia, Karolinska Institutet, St. Justine's Hospital, Johns Hopkins All Children's Hospital, Sanford Health, Seattle Children's Hospital, Eastern Virginia Medical School, Children's Hospital Colorado, University of Minnesota, The University of Texas Health Science Center, Houston, Phoenix Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Bettina F Cuneo, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920346
- Sponsor's protocol ID
- 13-1879
- Status last verified
- Jun 2021
- First submitted
- 3 Aug 2016
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cuneo BF, Strasburger JF, Niksch A, Ovadia M, Wakai RT. An expanded phenotype of maternal SSA/SSB antibody-associated fetal cardiac disease. J Matern Fetal Neonatal Med. 2009 Mar;22(3):233-8. doi: 10.1080/14767050802488220.
PubMed 19330707Cuneo BF, Lee M, Roberson D, Niksch A, Ovadia M, Parilla BV, Benson DW. A management strategy for fetal immune-mediated atrioventricular block. J Matern Fetal Neonatal Med. 2010 Dec;23(12):1400-5. doi: 10.3109/14767051003728237. Epub 2010 Apr 12.
PubMed 20384469Cuneo BF, Sonesson SE, Levasseur S, Moon-Grady AJ, Krishnan A, Donofrio MT, Raboisson MJ, Hornberger LK, Van Eerden P, Sinkovskaya E, Abuhamad A, Arya B, Szwast A, Gardiner H, Jacobs K, Freire G, Howley L, Lam A, Kaizer AM, Benson DW, Jaeggi E. Home Monitoring for Fetal Heart Rhythm During Anti-Ro Pregnancies. J Am Coll Cardiol. 2018 Oct 16;72(16):1940-1951. doi: 10.1016/j.jacc.2018.07.076.
PubMed 30309472
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor
- ClinicalTrials.gov ID
- NCT02920346
- Acronym / sponsor ID
- 13-1879
- Keywords
- Neonatal Systemic lupus erythematosus, Sjogren's syndrome, Fetal Atrioventricular Block, Fetal Heart Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's National Research Institute, Stollery Children's Hospital, The Hospital for Sick Children, New York Presbyterian Hospital, University of California, San Francisco, Children's Hospital of Philadelphia, Karolinska Institutet, St. Justine's Hospital, Johns Hopkins All Children's Hospital, Sanford Health, Seattle Children's Hospital, Eastern Virginia Medical School, Children's Hospital Colorado, University of Minnesota, The University of Texas Health Science Center, Houston, Phoenix Children's Hospital
- Study start
- Mar 2014 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will include all pregnant women with positive SSA or SSA and SSB antibodies between the gestational ages of 16-19 weeks with no signs of antibody-mediated fetal cardiac disease on pre-enrollment fetal echocardiogram. Subjects who are more than 19 weeks gestation will not be included. Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Background: PubMed 19330707Cuneo BF, Strasburger JF, Niksch A, Ovadia M, Wakai RT. An expanded phenotype of maternal SSA/SSB antibody-associated fetal cardiac disease. J Matern Fetal Neonatal Med. 2009 Mar;22(3):233-8. doi: 10.1080/14767050802488220.
- Background: PubMed 20384469Cuneo BF, Lee M, Roberson D, Niksch A, Ovadia M, Parilla BV, Benson DW. A management strategy for fetal immune-mediated atrioventricular block. J Matern Fetal Neonatal Med. 2010 Dec;23(12):1400-5. doi: 10.3109/14767051003728237. Epub 2010 Apr 12.
- Derived from this study: PubMed 30309472Cuneo BF, Sonesson SE, Levasseur S, Moon-Grady AJ, Krishnan A, Donofrio MT, Raboisson MJ, Hornberger LK, Van Eerden P, Sinkovskaya E, Abuhamad A, Arya B, Szwast A, Gardiner H, Jacobs K, Freire G, Howley L, Lam A, Kaizer AM, Benson DW, Jaeggi E. Home Monitoring for Fetal Heart Rhythm During Anti-Ro Pregnancies. J Am Coll Cardiol. 2018 Oct 16;72(16):1940-1951. doi: 10.1016/j.jacc.2018.07.076.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina F Cuneo, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome and Neonatal Systemic Lupus Erythematosus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.