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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined with aPL(+) | Experimental | the antiphospholipid antibodies appear in blood at least once |
|
| combined with aPL(-) | Experimental | the antiphospholipid antibodies never appear in blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulation | Drug | Drug:
Other Names: LMWH |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | Percentage of all patients that lead to live birth after 28 weeks of gestation | After 28 weeks of gestation] |
| Measure | Description | Time Frame |
|---|---|---|
| Early miscarriage | Spontaneous pregnancy loss within 10 weeks of gestation | within 10 weeks of gestation] |
| Intrauterine deaths | Spontaneous pregnancy loss after 10 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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:
Women who disagree or cannot complete the follow-up during pregnancy and after delivery.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Shu, Dr. | Contact | 0086-0531-82169654 | shuqiang@sdu.edu.cn | |
| Yunfei Guo, Bachelor | Contact | 0086-0531-82169654 | guoyunfei@mail.sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyun Yang, Dr. | Qilu Hospital of Shandong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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|
| Without Anticoagulation | Drug | Drug:
Other Names: HCQ |
|
| after 10 weeks of gestation |
| Stillbirth | Spontaneous pregnancy loss after 20 weeks of gestation | after 20 weeks of gestation |
| Intrauterine growth retardation (IUGR) | weight below the 10th percentile for the gestational age | between 28 and 37 weeks of gestation |
| Number of participants with low amniotic fluid during pregnancy | the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy | during pregnancy#an average of 10 months |
| Number of participants with abnormal S / D values during pregnancy | the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy | during pregnancy#an average of 10 months |