Understanding pregnancy outcomes in women with connective tissue diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Qilu Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Qiang Shu, Dr.
• Email: shuqiang@sdu.edu.cn
• Phone: 0086-0531-82169654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.