The Clinical Features and Pregnancy Outcomes of RA Patients

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how different treatments for rheumatoid arthritis (RA) affect women during pregnancy and the outcomes for both mothers and babies. The researchers are looking at women aged 20 to 45 who have been diagnosed with RA and are taking medications like prednisone, hydroxychloroquine, or TNF inhibitors. They want to understand how these treatments impact the mother's health, the safety of the baby, and how the pregnancy progresses.

To be eligible for this study, a woman must be 20 to 45 years old and have a confirmed diagnosis of RA. It is important that participants are willing to follow the treatment plan and attend follow-up appointments. If someone has certain health issues, like previous pregnancy losses or serious medical conditions, they won't be able to join the trial. Participants can expect to be monitored closely throughout their pregnancy to help gather important information about the safety and effectiveness of the RA treatments.

Gender

FEMALE

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 study
• • 1. Any known etiology of previous pregnancy loss
• • 1. Known paternal, maternal or embryonic chromosomal abnormalities.
• • 2. Maternal endocrine dysfunction: luteal insufficiency; polycystic ovary syndrome; premature ovarian failure (follicular phase stimulating hormone, FSH ≥ 20uU/L).
• • 3. Hyperprolactinemia; diabetes mellitus; other abnormalities of the hypothalamic pituitary-adrenal axis.
• • 4. Maternal anatomical abnormalities: uterine malformations; Asherman syndrome; cervical insufficiency; uterine fibrosis greater than 5 cm. vaginal infection.
• • 5. Any known serious cardiac, hepatic, renal, hematologic or endocrine disease.
• • 2. Any active infection, including bacterial, alisla virus (VZV), human immunodeficiency virus (HIV), human papillomavirus (HPV), syphilis, tuberculosis, fungal infections, etc.
• • 3. Hypersensitivity to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin
• • 4. History of the following diseases.
• • 1. Past history of peptic ulcer or upper gastrointestinal bleeding.
• • 2. Past history of malignancy.
• • 3. Past history of epilepsy or mental disorder.
• • 4. Female has been diagnosed with SLE
• • 5. Women who do not consent or are unable to complete pregnancy and postpartum follow-up.

Trial Officials