Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus; Pregnancy Related
• Intervention / Treatment: Drug: Anticoagulation; Drug: Without Anticoagulation

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yunfei Guo, Bachelor; Phone Number: 0086-0531-82169654; Email: guoyunfei@mail.sdu.edu.cn
• Study Contact Backup: Name: Qiang Shu, Dr.; Phone Number: 0086-0531-82169654; Email: shuqiang@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu hospital
      • Contact: Xiaoyun Yang, Dr; Phone Number: 0086-0531-82169166; Email: qlyykyc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Study Population

female with pregnance in accordance with the diagnostic criteria of SLE

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined with aPL(+); the antiphospholipid antibodies appear in blood at least once	Drug: Anticoagulation; Drug: Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred; Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.Other Names: HCQ; 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; 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: Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred; Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ
Experimental: combined with aPL(-); the antiphospholipid antibodies never appear in blood	Drug: Anticoagulation; Drug: Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred; Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.Other Names: HCQ; 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; 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: Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred; Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate	Percentage of all patients that lead to live birth after 28 weeks of gestation	After 28 weeks of gestation]

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Director: Xiaoyun Yang, Dr., Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: clinical features; Risk factors; Systemic Lupus Erythematosus; Pregnancy Related
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: SLE with Pregnancy QiluH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No