Status:
RECRUITING
The Clinical Features and Pregnancy Outcomes of CTD Patients
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Connective Tissue Diseases
Pregnancy Related
Eligibility:
FEMALE
20-45 years
Brief Summary
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 ...
Detailed 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 Goth...
Eligibility Criteria
Inclusion
- Women who meet the following inclusion criteria will be eligible to participate in the study:
- Age between 20-45 years;
- Diagnosed with APS: patients meet the Sydney classification criteria;
- 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.
- Participate voluntarily in this study, willing to use medication and follow-up according to treatment plan, and sign informed consent.
Exclusion
- Women who meet any of the following criteria will be excluded from the study:
- Any known etiology of previous pregnancy loss:
- Known paternal, maternal or embryo chromosome abnormality.
- Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase);
- hyperprolactinemia; diabetes mellitus; other hypothalamic pituitary-adrenal axis abnormality
- Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.Vaginal infection.
- 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.
- Disease history as follows:
- Past history of digestive ulcers or upper gastrointestinal hemorrhage.
- Past history of malignancy.
- Past history of epilepsia or psychotic disorders.
- Women have been diagnosed with Systemic lupus erythematosus
- 6\. Women who disagree or cannot complete pregnancy and follow-up after delivery.
Key Trial Info
Start Date :
September 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04918524
Start Date
September 11 2018
End Date
December 31 2026
Last Update
November 18 2023
Active Locations (1)
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1
Qilu Hospital
Jinan, Shandong, China, 250012