The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
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.
详细描述
Objective
To study the risk factors of poor pregnancy outcomes in CTD patients, and evaluate impact of different therapies on the maternal and fetal health.
Methods: Our department and Shanghai Gothic Network Technology Co.Ltd. jointly established the chronic disease management of CTD patients during pregnancy and lactation by using Smart System of Disease Management (SSDM). With this platform, patients in pregnancy can consult with rheumatologists face to face and follow-up regularly.
Follow-up: Consultation and followup will be scheduled every 4 weeks from confirmed pregnancy until delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who meet the following inclusion criteria will be eligible to participate in the study:
- •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.
排除标准
- •Women who meet any of the following criteria will be excluded from the study:
- •1.Any known etiology of previous pregnancy loss:
- •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.
- •Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:
- •Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.
- •Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.
- •4.Disease history as follows:
- •Past history of digestive ulcers or upper gastrointestinal hemorrhage.
- •Past history of malignancy.
- •Past history of epilepsia or psychotic disorders.
- •5.Women have been diagnosed with Systemic lupus erythematosus
- •Women who disagree or cannot complete pregnancy and follow-up after delivery.
研究组 & 干预措施
The Antiphospholipid syndrome (APS)
The cohort includes that patients who meet the proposed Sydney criteria.
干预措施: Prednisone (Drug)
The Antiphospholipid syndrome (APS)
The cohort includes that patients who meet the proposed Sydney criteria.
干预措施: Hydroxychloroquine (Drug)
The Antiphospholipid syndrome (APS)
The cohort includes that patients who meet the proposed Sydney criteria.
干预措施: Aspirin (Drug)
The Antiphospholipid syndrome (APS)
The cohort includes that patients who meet the proposed Sydney criteria.
干预措施: low molecular weight heparin Enoxaparin (Drug)
Undifferentiated connective tissue disease (UCTD)
The cohort includes the patients who are 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 antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD.
干预措施: Prednisone (Drug)
Undifferentiated connective tissue disease (UCTD)
The cohort includes the patients who are 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 antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD.
干预措施: Hydroxychloroquine (Drug)
Undifferentiated connective tissue disease (UCTD)
The cohort includes the patients who are 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 antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD.
干预措施: Aspirin (Drug)
Undifferentiated connective tissue disease (UCTD)
The cohort includes the patients who are 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 antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD.
干预措施: low molecular weight heparin Enoxaparin (Drug)
结局指标
主要结局
Live birth rate
时间窗: After 28 weeks of gestation
Percentage of all patients that lead to live birth after 28 weeks of gestation
次要结局
- Early fetal loss(within 10 weeks of gestation)
- Late fetal loss(after 10 weeks of gestation)
- Low-weight birth(after 28 weeks of gestation)
- Fetal growth retardation (FGR)(after 12 weeks of gestation)
- Number of participants with placental hematoma during pregnancy(during pregnancy, an average of 10 months)
- Gestational diabetes(through study completion, an average of 10 months)
- Stillbirth(after 20 weeks of gestation)
- Placental abruption(after 28 weeks of gestation)
- Number of participants with low amniotic fluid during pregnancy(after 12 weeks of gestation)
- Number of participants with abnormal S / D values during pregnancy(after 12 weeks of gestation)
- Eclampsia(after 20 weeks of gestation)
- Preterm delivery(between 28 and 37 weeks of gestation)
- Premature rupture of membranes(after 28 weeks of gestation)
- Number of participants with placental infarction(at delivery)
- Gestational hypertension(through study completion, an average of 10 months)
研究者
Qiang Shu
Chief Physician
Qilu Hospital of Shandong University