NCT04976465RecruitingPhase 1
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
Source: ClinicalTrials.gov · Last updated 18 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 9 Jun 2021
- Start date
- 1 Jan 2018
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Lupus (SLE)
- NCT number
- NCT04976465
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 200
- From 1 Jan 2018 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.
- 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.
Other
- Women who disagree or cannot complete the follow-up during pregnancy and after delivery.
Who the study is looking for
- Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
- Pregnant women aged 20-45 years old;
- Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Age in the registry: 20 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.