NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Systemic Lupus Erythematosus
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Anticoagulation	Drug: 1. Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred 2. Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ 3. 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 4. 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: 1. Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred 2. Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ

Timeline

• Start date: 2018-01-01
• Primary completion: 2025-07-30
• Completion: 2026-12-31
• First posted: 2021-07-26
• Last updated: 2023-11-18

Locations

1 site across 1 country: China