Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

NCT ID: NCT04976465

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Systemic Lupus Erythematosus; Pregnancy Related

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combined with aPL(+)

the antiphospholipid antibodies appear in blood at least once

Group Type: EXPERIMENTAL

Anticoagulation

Intervention Type: DRUG

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

Without Anticoagulation

Intervention Type: DRUG

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

combined with aPL(-)

the antiphospholipid antibodies never appear in blood

Group Type: EXPERIMENTAL

Anticoagulation

Intervention Type: DRUG

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

Without Anticoagulation

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qiang Shu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoyun Yang, Dr.

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Shu, Dr.

Role: CONTACT

shuqiang@sdu.edu.cn

0086-0531-82169654

Yunfei Guo, Bachelor

Role: CONTACT

guoyunfei@mail.sdu.edu.cn

0086-0531-82169654

Facility Contacts

Xiaoyun Yang, Dr

Role: primary

qlyykyc@163.com

0086-0531-82169166

Other Identifiers

SLE with Pregnancy QiluH

Identifier Type: -

Identifier Source: org_study_id