The Clinical Features and Pregnancy Outcomes of CTD Patients

Recruiting now

Conditions studied: Connective Tissue Diseases, Pregnancy Related

In brief

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.

Key facts

Study ID

NCT04918524

Run by

Qilu Hospital of Shandong University

People needed

126

Starts

2018-09-11

Expected to finish

2026-12-31

Last updated by the study team

2023-11-18

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.
• 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
• Women who disagree or cannot complete pregnancy and follow-up after delivery.

Where it is running

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

Full record on ClinicalTrials.gov

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