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RECRUITING
NCT04976465
PHASE1

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2018-01-01

Completion Date

2026-12-31

Last Updated

2023-11-18

Healthy Volunteers

No

Interventions

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

Locations (1)

Qilu Hospital

Jinan, Shandong, China