Understanding pregnancy outcomes in women with connective tissue diseases

The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study

This study is trying to understand how pregnancy goes for women with connective tissue diseases, especially those with antiphospholipid syndrome, by tracking their health and outcomes during pregnancy with regular check-ins from doctors.

Quick facts

• Study type: Observational
• Enrollment: 126 (estimated)
• Ages: 20 Years to 45 Years
• Sex: Female
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT04918524 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the clinical features and pregnancy outcomes of women diagnosed with connective tissue diseases (CTD), particularly focusing on those with antiphospholipid syndrome (APS) and undifferentiated connective tissue disease (UCTD). The study will utilize a Smart System of Disease Management (SSDM) platform to facilitate regular consultations and follow-ups with rheumatologists throughout the pregnancy. By identifying risk factors associated with poor pregnancy outcomes and evaluating the impact of various therapies, the study seeks to enhance maternal and fetal health for these patients. Follow-up consultations will occur every four weeks from confirmed pregnancy until delivery.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 20-45 who have been diagnosed with APS or UCTD and are willing to participate in the study and adhere to the treatment plan.

Not a fit: Patients with known etiologies of previous pregnancy loss or specific chromosomal abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into managing pregnancy in women with connective tissue diseases, potentially improving outcomes for both mothers and infants.

How similar studies have performed: Other studies have explored pregnancy outcomes in women with autoimmune diseases, suggesting that this approach may yield meaningful insights, although the specific focus on CTD and pregnancy outcomes is less commonly studied.

Eligibility criteria

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:

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

  3\. 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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Qiang Shu, Dr.

Conditions Connective Tissue Diseases; Pregnancy Related; Connective tissue disease; Pregnancy outcomes; Clinical features; Risk factors