drugset
drugset / Trial / NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

NCT04976465 ↗

Phase 1 Recruiting 200 enrolled Qilu Hospital of Shandong University
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2018-01-01
Primary completion
2025-07-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg Oral
Subject Enoxaparin sodium Other / unclassified 40 mg Subcutaneous
Subject Enoxaparin sodium Other / unclassified 60 mg Subcutaneous
Background Hydroxychloroquine Small molecule 100 mg Oral
Background Hydroxychloroquine Small molecule 200 mg Oral
Background Prednisone Other / unclassified 5 mg Oral
Background Prednisone Other / unclassified 30 mg Oral

Indications

pregnancy disorder systemic lupus erythematosus