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Search / Trial NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Jul 15, 2021

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Systemic Lupus Erythematosus Pregnancy Related Clinical Features Risk Factors

ClinConnect Summary

This clinical trial is focused on understanding how to best treat women with systemic lupus erythematosus (SLE) during pregnancy. SLE is an autoimmune disease that can affect multiple organs, and pregnant women with this condition often face higher risks of complications like premature delivery and preeclampsia. The study aims to monitor the health of both the mother and baby while ensuring effective treatment for SLE throughout pregnancy.

To be eligible for this trial, women need to be between the ages of 20 and 45 and have a confirmed diagnosis of SLE. Participants must be willing to follow the treatment plan and attend all follow-up appointments. Throughout the study, participants can expect regular check-ups to monitor their health and the health of their baby. It's important to note that women with certain health issues or specific medical histories may not be able to participate. This trial is currently recruiting participants, and it could provide valuable insights that help improve care for pregnant women with SLE.

Gender

FEMALE

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.

About Qilu Hospital Of Shandong University

Qilu Hospital of Shandong University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Affiliated with Shandong University, the hospital integrates clinical practice with education and research, fostering an environment that promotes scientific discovery and the development of new therapies. With a commitment to high standards of clinical excellence and ethical research practices, Qilu Hospital plays a pivotal role in enhancing patient outcomes and contributing to the global medical community through a diverse range of clinical trials and studies.

Locations

Jinan, Shandong, China

Patients applied

0 patients applied

Trial Officials

Xiaoyun Yang, Dr.

Study Director

Qilu Hospital of Shandong University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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