Clinical trial NCT04976465: Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
Official title: Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Pregnancy Related
Keywords: Systemic Lupus Erythematosus
Pregnancy Related
clinical features
Risk factors
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Live birth rate
timeFrame: After 28 weeks of gestation]
Secondary outcomes:
measure: Early miscarriage
timeFrame: within 10 weeks of gestation]
measure: Intrauterine deaths
timeFrame: after 10 weeks of gestation
measure: Stillbirth
timeFrame: after 20 weeks of gestation
measure: Intrauterine growth retardation (IUGR)
timeFrame: between 28 and 37 weeks of gestation
measure: Number of participants with low amniotic fluid during pregnancy
timeFrame: during pregnancy#an average of 10 months
measure: Number of participants with abnormal S / D values during pregnancy
timeFrame: during pregnancy#an average of 10 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiaoyun Yang, Dr.
role: STUDY_DIRECTOR
References: