Fetal-Hope Study: Home Monitoring of Fetal Heart Rate in SSA+ Pregnant Women

NCT05958446 | Recruiting

• 1 other identifier: 2021/ST/247
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Serological positivity for anti Ro-SSA antibodies is frequently found in pathologies such as Sjogren's Syndrome and SLE. Worldwide, approximately 0.5-1% of women of reproductive age are positive for Ro-SSA antibodies, and in 1-2% of these women, pregnancy will be complicated by cardiac abnormalities of the fetus, particularly varying degrees of atrioventricular block. It is essential to promptly identify patients with fetal heart rhythm abnormalities to prevent both intrauterine deaths and the birth of newborns with third-degree atrioventricular block, requiring lifelong cardiac pacing. At the moment, the only means to identify these alterations is represented by fetal cardiac ultrasound. Fetal atrioventricular block can develop within a few hours in these patients and fetal ultrasound, normally performed no more frequently than once every two weeks, does not allow for the timely identification of these conditions and therefore for pharmacological intervention. Using home fetal heart rate monitoring, carried out directly by patients three times a day with the aid of a special device that allows easy identification of the fetal heart rhythm, would allow rapid recognition of rhythm alterations and early access to confirmation tests and possible therapies. Fetal heart rhythm surveillance could detect a medically reversible disease that, if untreated, would progress to lifelong cardiac pacing, with its many associated comorbidities. Applying such protocol in pregnant women anti-Ro/SSA positive could become standard practice. The main objectives of this study are:

• Estimation of the incidence of the development of fetal AV conduction abnormalities in patients with positivity for Ro/SSA autoantibodies;
• Estimation of the reliability of home monitoring of fetal heart rate with fetal Doppler device in detecting fetal atrioventricular conduction disturbances;
• Evaluation of the results of the therapy administered early, immediately after the diagnosis of fetal atrioventricular conduction disorders.

Conditions

Pregnancy Related; Autoimmune Diseases; Neonatal Lupus; SLE; Sjogren's Syndrome; Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Keywords

sjogren's syndrome; SSA; SLE; pregnancy; fetal heart rate; neonatal lupus

Outcome Measures

Primary Outcomes (1)

• Incidence of fetal atrio-ventricular block evaluated as percentage of patients experiencing a fetal atrio-ventricular block.

  Estimation of the incidence of fetal heart disease in pregnant patients with positive SSA autoantibodies

  8 months

Secondary Outcomes (5)

• Home fetal heart rate monitoring reliability: percentage of patients reporting alterations of fetal heart rhythm detected by the hand-held fetal heart rate doppler.

  5 months

• Therapies' outcomes: percentage of patients where fetal atrio-ventricular block will be reverted by the use of individualized therapies.

  8 months

• Pregnancy outcome other than atrio-ventricular block reported as percentage of newborns presenting other symptoms of neonatal lupus, subgroup: hepatologic manifestations.

  8 months

• Pregnancy outcome other than atrio-ventricular block. Percentage of newborns presenting other symptoms of neonatal lupus, subgroup: haematologic manifestations.

  8 months

• Pregnancy outcome other than atrio-ventricular block. Percentage of newborns presenting other symptoms of neonatal lupus, subgroup: skin conditions.

  8 months

Study Arms (1)

Pregnant women with SSA Auto Ab

All patients over the age of 18, who will sign the informed consent for participation in the study, characterized by the positivity of autoantibodies against Ro/SSA who will become pregnant during the enrollment period.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients over the age of 18 characterized by the positivity of autoantibodies against Ro/SSA who will become pregnant during the enrollment period in the enrolling centres.

You may qualify if:

• All patients over the age of 18 will be enrolled in the study, who will sign the informed consent for participation in the study, characterized by the positivity of autoantibodies against Ro/SSA who will become pregnant during the enrollment period in the enrolling centres.

You may not qualify if:

• None

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

ASST Fatebenefratelli e Sacco

Milan, 20121, Italy

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Autoimmune Diseases; Neonatal Systemic lupus erythematosus; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Antonio Luca Brucato, Prof

  ASST Fatebenefratelli, Milano, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuele Bizzi, Dr

CONTACT

+393299636442; bizzi.emanuele@gmail.com

Antonio L Brucato, Prof

CONTACT

+390263632500; antonio.brucato@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 24, 2023
• Study Start: April 14, 2022
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2026
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)