The Clinical Features and Pregnancy Outcomes of CTD Patients

Shandong University

Status: Enrolling

Conditions: Connective Tissue Diseases; Pregnancy Related

Treatments: Drug: low molecular weight heparin Enoxaparin; Drug: Hydroxychloroquine; Drug: Aspirin; Drug: Prednisone

Study type: Observational

Funder types: Other

Identifiers

NCT04918524

CTD with Pregnancy QiluH

Details and patient eligibility

About

Connective tissue disease (CTD) is a common group of autoimmune diseases, mainly including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS) , and so on. APS is caused by autoimmune disorders that cause recurrent miscarriage, thrombosis, and thrombocytopenia, and often secondary to connective tissue diseases such as SLE. Undifferentiated connective tissue disease (UCTD) is currently considered to be an independent disease in the classification of CTD. And women of childbearing age who suffer UCTD is more common than that in other definite CTDs. Therefore, the impact of the disease flare and the influence of medicine on pregnancy and lactation are important for these patients who may suffer high-risk of abnormal pregnance.

Full description

Objective: To study the risk factors of poor pregnancy outcomes in CTD patients, and evaluate impact of different therapies on the maternal and fetal health.

Methods: Our department and Shanghai Gothic Network Technology Co.Ltd. jointly established the chronic disease management of CTD patients during pregnancy and lactation by using Smart System of Disease Management (SSDM). With this platform, patients in pregnancy can consult with rheumatologists face to face and follow-up regularly.

Follow-up: Consultation and followup will be scheduled every 4 weeks from confirmed pregnancy until delivery.

Enrollment: 126 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who meet the following inclusion criteria will be eligible to participate in the study:

  1. Age between 20-45 years;
  2. Diagnosed with APS: patients meet the Sydney classification criteria;
  3. Diagnosed with UCTD: at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-extractable nuclear antigen (ENA) antibodies, anti-doublestranded DNA (ds-DNA) antibody, antiphospholipid antibody(aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting connective tissue disease(CTD) , while not fulfilling any classification criteria of a defined CTD.
  4. Participate voluntarily in this study, willing to use medication and follow-up according to treatment plan, and sign informed consent.

Exclusion criteria

• Women who meet any of the following criteria will be excluded from the study:

  1.Any known etiology of previous pregnancy loss:

  1. Known paternal, maternal or embryo chromosome abnormality.

  2. Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase);

  3. hyperprolactinemia; diabetes mellitus; other hypothalamic pituitary-adrenal axis abnormality

  4. Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.Vaginal infection.

  5. Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:

  6. Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.

  7. Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.

  4.Disease history as follows:

  1. Past history of digestive ulcers or upper gastrointestinal hemorrhage.
  2. Past history of malignancy.
  3. Past history of epilepsia or psychotic disorders.

  5.Women have been diagnosed with Systemic lupus erythematosus

  6. Women who disagree or cannot complete pregnancy and follow-up after delivery.

Trial design

126 participants in 2 patient groups

The Antiphospholipid syndrome (APS)

Description:

The cohort includes that patients who meet the proposed Sydney criteria.

Treatment:

Drug: Prednisone

Drug: Aspirin

Drug: Hydroxychloroquine

Drug: low molecular weight heparin Enoxaparin

Undifferentiated connective tissue disease (UCTD)

Description:

The cohort includes the patients who are diagnosed with UCTD: at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-extractable nuclear antigen (ENA) antibodies, anti-doublestranded DNA (ds-DNA) antibody, antiphospholipid antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD.

Treatment:

Drug: Prednisone

Drug: Aspirin

Drug: Hydroxychloroquine

Drug: low molecular weight heparin Enoxaparin