Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| combined with aPL(+) the antiphospholipid antibodies appear in blood at least once |
Drug: Anticoagulation
Drug:
Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names: HCQ
Aspirin 100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response to 32 weeks of pregnancy. 75mg po, once per day (Qd) to 34 weeks of pregnancy. 50mg po, once per day (Qd) to 36 weeks of pregnancy.
Other Names: Asp
Low molecular weight heparin Enoxaparin 40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
Other Names: LMWH
Drug: Without Anticoagulation
Drug:
Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names: HCQ
|
| combined with aPL(-) the antiphospholipid antibodies never appear in blood |
Drug: Anticoagulation
Drug:
Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names: HCQ
Aspirin 100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response to 32 weeks of pregnancy. 75mg po, once per day (Qd) to 34 weeks of pregnancy. 50mg po, once per day (Qd) to 36 weeks of pregnancy.
Other Names: Asp
Low molecular weight heparin Enoxaparin 40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
Other Names: LMWH
Drug: Without Anticoagulation
Drug:
Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names: HCQ
|
Outcome Measures
Primary Outcome Measures
- Live birth rate [After 28 weeks of gestation]]
Percentage of all patients that lead to live birth after 28 weeks of gestation
Secondary Outcome Measures
- Early miscarriage [within 10 weeks of gestation]]
Spontaneous pregnancy loss within 10 weeks of gestation
- Intrauterine deaths [after 10 weeks of gestation]
Spontaneous pregnancy loss after 10 weeks of gestation
- Stillbirth [after 20 weeks of gestation]
Spontaneous pregnancy loss after 20 weeks of gestation
- Intrauterine growth retardation (IUGR) [between 28 and 37 weeks of gestation]
weight below the 10th percentile for the gestational age
- Number of participants with low amniotic fluid during pregnancy [during pregnancy#an average of 10 months]
the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy
- Number of participants with abnormal S / D values during pregnancy [during pregnancy#an average of 10 months]
the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
- Study Director: Xiaoyun Yang, Dr., Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SLE with Pregnancy QiluH