The Clinical Features and Pregnancy Outcomes of CTD Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Prednisone
  • Hydroxychloroquine
  • Aspirin
  • low molecular weight heparin Enoxaparin

Treatment groups

126 Participants
are divided into 2 treatment groups