Evaluating treatment outcomes for pregnant women with systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the risk factors associated with poor pregnancy outcomes in women diagnosed with systemic lupus erythematosus (SLE). It will evaluate the impact of different therapeutic approaches, including anticoagulation, on both maternal and fetal health. Utilizing a Smart System of Disease Management, patients will receive regular consultations and follow-ups with rheumatologists throughout their pregnancy. The study will monitor disease activity and treatment adherence from the time of confirmed pregnancy until delivery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Qilu Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Qiang Shu, Dr.
• Email: shuqiang@sdu.edu.cn
• Phone: 0086-0531-82169654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.