NCT04976465 Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
| NCT ID | NCT04976465 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2025-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2018-01-01 with a primary completion date of 2025-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Xiaoyun Yang, Dr.
STUDY DIRECTOR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT04976465 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 45 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04976465 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04976465 currently recruiting?
Yes, NCT04976465 is actively recruiting participants. Contact the research team at shuqiang@sdu.edu.cn for enrollment information.
Where is the NCT04976465 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT04976465 clinical trial?
NCT04976465 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Xiaoyun Yang, Dr. at Qilu Hospital of Shandong University. The trial plans to enroll 200 participants.
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