Evaluating treatment outcomes for pregnant women with systemic lupus erythematosus
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
This study is testing how different treatments for systemic lupus erythematosus during pregnancy can affect the health of both mothers and their babies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT04976465 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 20-45 years who have been diagnosed with systemic lupus erythematosus.
Not a fit: Patients with known causes of previous abortions or serious comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for pregnant women with SLE, enhancing maternal and fetal health outcomes.
How similar studies have performed: While there have been studies on SLE and pregnancy, this approach utilizing a dedicated disease management system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Qiang Shu, Dr.
- Email: shuqiang@sdu.edu.cn
- Phone: 0086-0531-82169654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.