Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Recruiting now · Phase 1

Conditions studied: Systemic Lupus Erythematosus, Pregnancy Related

In brief

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.

Key facts

Study ID

NCT04976465

Run by

Qilu Hospital of Shandong University

People needed

200

Starts

2018-01-01

Expected to finish

2026-12-31

Last updated by the study team

2023-11-18

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Qilu Hospital — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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