Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Phase 1

Recruiting

• Conditions: Pregnancy Related; Systemic Lupus Erythematosus
• Interventions: Drug: Anticoagulation; Drug: Without Anticoagulation

• Registration Number: NCT04976465
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-07-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
combined with aPL(+)	Without Anticoagulation	the antiphospholipid antibodies appear in blood at least once
combined with aPL(-)	Anticoagulation	the antiphospholipid antibodies never appear in blood
combined with aPL(-)	Without Anticoagulation	the antiphospholipid antibodies never appear in blood
combined with aPL(+)	Anticoagulation	the antiphospholipid antibodies appear in blood at least once

Primary Outcome Measures

Name	Time	Method
Live birth rate	After 28 weeks of gestation]	Percentage of all patients that lead to live birth after 28 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Stillbirth	after 20 weeks of gestation	Spontaneous pregnancy loss after 20 weeks of gestation
Number of participants with low amniotic fluid during pregnancy	during pregnancy#an average of 10 months	the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy
Number of participants with abnormal S / D values during pregnancy	during pregnancy#an average of 10 months	the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy
Early miscarriage	within 10 weeks of gestation]	Spontaneous pregnancy loss within 10 weeks of gestation
Intrauterine deaths	after 10 weeks of gestation	Spontaneous pregnancy loss after 10 weeks of gestation
Intrauterine growth retardation (IUGR)	between 28 and 37 weeks of gestation	weight below the 10th percentile for the gestational age

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China