Actively Recruiting

Age: 20Years - 45Years
FEMALE
NCT04918524

The Clinical Features and Pregnancy Outcomes of CTD Patients

Led by Qilu Hospital of Shandong University · Updated on 2023-11-18

126

Participants Needed

1

Research Sites

433 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Clinical Features and Pregnancy Outcomes of CTD Patients

Who Can Participate

Age: 20Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 20 and 45 years
  • Diagnosed with antiphospholipid syndrome (APS) meeting Sydney classification criteria
  • Diagnosed with undifferentiated connective tissue disease (UCTD) with at least one auto-antibody and symptoms suggesting connective tissue disease but not meeting defined CTD criteria
  • Willing to participate voluntarily, follow treatment plans, and sign informed consent
Not Eligible

You will not qualify if you...

  • Known causes of previous pregnancy loss such as chromosome abnormalities in parents or embryo
  • Maternal endocrine dysfunctions including corpus luteal insufficiency, polycystic ovarian syndrome, premature ovarian failure, hyperprolactinemia, diabetes, or other hormone axis abnormalities
  • Maternal anatomical abnormalities like uterine malformation, Asherman syndrome, cervical incompetence, large uterine fibroids, or vaginal infection
  • Severe cardiac, liver, kidney, blood, or endocrine diseases
  • Active infections including varicella zoster virus, HIV, HPV, syphilis, or tuberculosis
  • Allergy to prednisone, hydroxychloroquine, low-molecular-weight heparin, or aspirin
  • History of digestive ulcers or upper gastrointestinal bleeding
  • History of cancer
  • History of epilepsy or psychotic disorders
  • Diagnosis of systemic lupus erythematosus
  • Unwillingness or inability to complete pregnancy and follow-up after delivery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qilu Hospital

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

Q

Qiang Shu, Dr.

CONTACT

S

Shuting Li

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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