The Clinical Features and Pregnancy Outcomes of CTD Patients

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Jun 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how connective tissue diseases (CTD), like antiphospholipid syndrome (APS) and undifferentiated connective tissue disease (UCTD), affect pregnancy and its outcomes. These diseases can lead to complications such as miscarriages and other pregnancy-related issues, making it crucial to understand how they impact women in their childbearing years. The researchers want to learn more about the experiences of women with these conditions during pregnancy and while breastfeeding, especially regarding how their symptoms and medications influence their health and their babies' health.

To participate in this study, women aged 20 to 45 who have been diagnosed with APS or UCTD may be eligible. They should have specific auto-antibodies and symptoms that suggest a connective tissue disease but not meet the criteria for a defined CTD. Participants will need to agree to follow a treatment plan and provide informed consent. Throughout the study, participants can expect regular follow-ups to monitor their health and pregnancy progress. This trial aims to provide valuable insights that could improve care for women facing these challenges during pregnancy.

Gender

FEMALE

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.