Studies outcomes and treatment of lupus patients during pregnancy
Compares blood-thinning treatment with no blood-thinning in pregnant women with lupus.
Plain-language title generated from the registry record
Registry title: Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women aged 20-45 with systemic lupus erythematosus (SLE) who will take their treatment and attend follow-up visits.
- Age
- 20 to 45 years
- Sex
- Women only
- Disease stage
- Diagnosed systemic lupus erythematosus (SLE) by ACR criteria, 1997, during pregnancy.
- Biomarker or test result
- Antiphospholipid antibodies in the blood decide the group: seen at least once, or never seen.
Main reasons for not taking part
- Known cause of an earlier miscarriage, such as chromosome problems, hormone problems or an abnormal womb
- Any serious heart, liver, kidney, blood or endocrine disease
- Any active infection, such as active hepatitis B or C, HPV, shingles, HIV, syphilis or tuberculosis
- Allergy to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin
- Past stomach ulcer or upper gut bleeding, cancer, epilepsy or psychosis
This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant women aged 20-45 years old;
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 45 years old?
Source: NCT04976465, who can take part
Where in China
- Qilu HospitalJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT04976465
- Record updated
- 18 November 2023
- Original description
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.Read full original descriptionShow less
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
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.
Inclusion: 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.
Exclusion: 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; 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; Women who disagree or cannot complete the follow-up during pregnancy and after delivery.