Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

NCT04976465 | Recruiting Phase 1

• 1 other identifier: SLE with Pregnancy QiluH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Pregnancy Related

Keywords

Systemic Lupus Erythematosus; Pregnancy Related; clinical features; Risk factors

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Percentage of all patients that lead to live birth after 28 weeks of gestation

  After 28 weeks of gestation]

Secondary Outcomes (6)

• Early miscarriage

  within 10 weeks of gestation]

• Intrauterine deaths

  after 10 weeks of gestation

• Stillbirth

  after 20 weeks of gestation

• Intrauterine growth retardation (IUGR)

  between 28 and 37 weeks of gestation

• Number of participants with low amniotic fluid during pregnancy

  during pregnancy#an average of 10 months

Study Arms (2)

combined with aPL(+)

EXPERIMENTAL

the antiphospholipid antibodies appear in blood at least once

Drug: Anticoagulation; Drug: Without Anticoagulation

combined with aPL(-)

EXPERIMENTAL

the antiphospholipid antibodies never appear in blood

Drug: Anticoagulation; Drug: Without Anticoagulation

Interventions

Anticoagulation 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

combined with aPL(+); combined with aPL(-)

Without Anticoagulation 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(+); combined with aPL(-)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaoyun Yang, Dr.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Qiang Shu, Dr.

CONTACT

0086-0531-82169654; shuqiang@sdu.edu.cn

Yunfei Guo, Bachelor

CONTACT

0086-0531-82169654; guoyunfei@mail.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 26, 2021
• Study Start: January 1, 2018
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)