Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Shandong University

Status and phase: Enrolling; Phase 1

Conditions: Pregnancy Related; Systemic Lupus Erythematosus

Treatments: Drug: Anticoagulation; Drug: Without Anticoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04976465

SLE with Pregnancy QiluH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
2. Pregnant women aged 20-45 years old;
3. Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.

Exclusion criteria

1. 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.

2. 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.

3. Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.

4. 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.

5. Women who disagree or cannot complete the follow-up during pregnancy and after delivery.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

combined with aPL(+)

Experimental group

Description:

the antiphospholipid antibodies appear in blood at least once

Treatment:

Drug: Without Anticoagulation

Drug: Anticoagulation

combined with aPL(-)

Experimental group

Description:

the antiphospholipid antibodies never appear in blood

Treatment:

Drug: Without Anticoagulation

Drug: Anticoagulation