Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Since SLE patients usually have disease activity during pregnancy and postpartum, and a variety of maternal and fetal diseases are closely related to SLE, it is very important to monitor the disease activity and drug treatment of SLE patients during pregnancy.
详细描述
Objective
To study the risk factors of poor pregnancy outcomes in SLE 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 SLE 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
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
- •Pregnant women aged 20-45 years old;
- •Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
排除标准
- •The cause of previous abortion was known:
- •Known chromosomal abnormalities in the parent, maternal or embryo.
- •Page 3 of 4 [DRAFT] -• Endocrine dysfunction of pregnant women: luteal dysfunction; Polycystic ovarian syndrome; Ovarian premature failure (FSH
- •≥ 20uu/ L) in follicular stage;
- •Hyperprolactinemia thyroid disease; Other hypothalamic pituitary adrenal axis abnormalities in diabetes mellitus.
- •Abnormal anatomy of pregnant women: abnormal uterus; Asherman syndrome; The uterine fibrosis of cervical insufficiency is more than 5 cm. Vaginal infection.
- •Any known serious heart disease, liver, kidney, blood or endocrine disease.
- •Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
- •Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.
- •The history of the disease is as follows:
- •There was a history of peptic ulcer or upper gastrointestinal bleeding in the past.
- •The past history of malignant tumor.
- •The past history of epilepsy or psychosis.
- •Women who disagree or cannot complete the follow-up during pregnancy and after delivery.
研究组 & 干预措施
combined with aPL(+)
the antiphospholipid antibodies appear in blood at least once
干预措施: Anticoagulation (Drug)
combined with aPL(+)
the antiphospholipid antibodies appear in blood at least once
干预措施: Without Anticoagulation (Drug)
combined with aPL(-)
the antiphospholipid antibodies never appear in blood
干预措施: Anticoagulation (Drug)
combined with aPL(-)
the antiphospholipid antibodies never appear in blood
干预措施: Without Anticoagulation (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
- Stillbirth(after 20 weeks of gestation)
- Number of participants with low amniotic fluid during pregnancy(during pregnancy#an average of 10 months)
- Number of participants with abnormal S / D values during pregnancy(during pregnancy#an average of 10 months)
- Early miscarriage(within 10 weeks of gestation])
- Intrauterine deaths(after 10 weeks of gestation)
- Intrauterine growth retardation (IUGR)(between 28 and 37 weeks of gestation)
研究者
Qiang Shu
Chief Physician
Qilu Hospital of Shandong University