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Recruiting NCT05651373

The Clinical Features and Pregnancy Outcomes of RA Patients

Conditions: Rheumatoid Arthritis, Pregnancy Related

Sex: Female
Ages: 20 Years – 45 Years
Enrollment: 100
Sponsor: Qilu Hospital of Shandong University

Location: China

Summary

This study includes RA patients in pregnancy, who are using different treatment regimens,including prednisone, hydroxychloroquine, and/or TNF inhibitors. The maternal disease activity, pregnancy outcomes, maternal and fetal safety are assessing during the trimester of pregnancy. The effects of different therapies and risk factors for adverse pregnancy outcomes will be analysis.

Eligibility Criteria

Inclusion Criteria:- 1.Age between 20 and 45 years old.2.Diagnosis of RA: Approved by the American College of Rheumatology and the European League Against Rheumatism in 2010.Involved joints 1 large joint (0 points) 2-10 large joints (1 point) 1-3 small joints (with or without large joints) (2 points) 4-10 small joints (with or without large joints) (3 points) more than 10 small joints (at least one small joint) (5 points)Serological indicators RF and ACPA negative (0 points) RF and ACPA, at least one of which is low titer positive. (2 points) RF and ACPA with at least one high titer positive (3 points)Acute chronotropic reactants Both CRP and ESR normal (0 points) Abnormal CRP or ESR (1 point)Duration of synovitis <6 weeks (0 points)≥6 weeks (1 point)3.Voluntary participation in this study, willingness to administer medication and follow up according to the treatment plan, and signing of an informed consent form.Exclusion Criteria:Women who meet any of the following criteria will be excluded from the studyAny known etiology of previous pregnancy lossKnown paternal, maternal or embryonic chromosomal abnormalities.Maternal endocrine dysfunction: luteal insufficiency; polycystic ovary syndrome; premature ovarian failure (follicular phase stimulating hormone, FSH ≥ 20uU/L).Hyperprolactinemia; diabetes mellitus; other abnormalities of the hypothalamic pituitary-adrenal axis.Maternal anatomical abnormalities: uterine malformations; Asherman syndrome; cervical insufficiency; uterine fibrosis greater than 5 cm. vaginal infection.Any known serious cardiac, hepatic, renal, hematologic or endocrine disease.Any active infection, including bacterial, alisla virus (VZV), human immunodeficiency virus (HIV), human papillomavirus (HPV), syphilis, tuberculosis, fungal infections, etc.Hypersensitivity to prednisone, hydroxychloroquine, low molecular weight heparin or aspirinHistory of the following diseases.Past history of peptic ulcer or upper gastrointestinal bleeding.Past history of malignancy.Past history of epilepsy or mental disorder.Female has been diagnosed with SLEWomen who do not consent or are unable to complete pregnancy and postpartum follow-up.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05651373). StuddyBuddy aggregates publicly available trial information.