Clinical trial NCT05651373: The Clinical Features and Pregnancy Outcomes of RA Patients
Official title: The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Pregnancy Related
Keywords: Rheumatoid Arthritis
Pregnancy outcomes
Clinical features
Risk factors
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female with pregnance in accordance with the diagnostic criteria of Rheumatoid arthritis in 2010.

Brief 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.

Detailed description: To study the risk factors of poor pregnancy outcomes in RA patients, and evaluate impact of different therapies on the maternal and fetal health.

The follow-up study will be scheduled every 4 weeks from confirmed pregnancy until delivery, records the disease activity of RA, pregnancy outcome and safety with the help of the "smart disease management system (SSDM)" and face-to-face consultations.

The effects of different therapies on maternal and fetal will be valued

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.

Primary outcomes:
measure: The percentage of patients who achieve clinical remission using DAS28-CRP
timeFrame: through study completion, an average of 10 months
Secondary outcomes:
measure: Early fetal loss
timeFrame: within 10 weeks of gestation
measure: Late fetal loss
timeFrame: after 10 weeks of gestation
measure: Still birth
timeFrame: after 10 weeks of gestation
measure: Preterm delivery
timeFrame: between 28 and 37 weeks of gestation
measure: Low-weight birth
timeFrame: after 28 weeks of gestation
measure: Premature rupture of membranes
timeFrame: after 28 weeks of gestation
measure: Placental abruption
timeFrame: after 28 weeks of gestation
measure: Fetal growth retardation (FGR)
timeFrame: after 12 weeks of gestation
measure: Number of participants with low amniotic fluid during pregnancy
timeFrame: after 12 weeks of gestation
measure: Number of participants with abnormal S / D values during pregnancy
timeFrame: after 12 weeks of gestation
measure: Number of participants with placental hematoma during pregnancy
timeFrame: during pregnancy
measure: Eclampsia
timeFrame: after 20 weeks of gestation
measure: Gestational diabetes
timeFrame: through study completion, an average of 10 months
measure: Gestational hypertension
timeFrame: through study completion, an average of 10 months
measure: Number of participants with placental infarction
timeFrame: at delivery
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: through study completion, an average of 10 months
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: through study completion, an average of 10 months
measure: Live birth rate
timeFrame: After 28 weeks of gestation
measure: Change from baseline Simplified Disease Activity Index (SDAI)
timeFrame: through study completion, an average of 10 months
measure: Change from baseline Clinical Disease Activity Index (CDAI)
timeFrame: through study completion, an average of 10 months
measure: swollen joint number (SW28)
timeFrame: through study completion, an average of 10 months
measure: tenderness joint number (T28)
timeFrame: through study completion, an average of 10 months
measure: patient global assessment(PGA)
timeFrame: through study completion, an average of 10 months
measure: Health Assessment Questionnaire (HAQ)
timeFrame: through study completion, an average of 10 months
measure: Percentage of patients achieving Boolean remission
timeFrame: through study completion, an average of 10 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiaoyun Yang
role: STUDY_DIRECTOR
References: