RecruitingPhase 1NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

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


Sponsor

Qilu Hospital of Shandong University

Enrollment

200 participants

Start Date

Jan 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anticoagulation and a drug called Without Anticoagulation for people with pregnancy related and systemic lupus erythematosus. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 20 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnticoagulation

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

DRUGWithout 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


Locations(1)

Qilu Hospital

Jinan, Shandong, China

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NCT04976465


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