Actively Recruiting

Phase 1
Age: 20Years - 45Years
FEMALE
NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Led by Qilu Hospital of Shandong University · Updated on 2023-11-18

200

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Who Can Participate

Age: 20Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with systemic lupus erythematosus (SLE) according to ACR criteria (1997)
  • Pregnant women aged 20 to 45 years
  • Willing to participate, follow the treatment plan, and sign informed consent
Not Eligible

You will not qualify if you...

  • Known cause of previous abortion including chromosomal abnormalities or endocrine dysfunction
  • Abnormal anatomy of the uterus or serious infections like hepatitis B or C, HIV, syphilis, or tuberculosis
  • Allergic to prednisone, hydroxychloroquine, low molecular weight heparin, or aspirin
  • History of peptic ulcer, upper gastrointestinal bleeding, malignant tumor, epilepsy, or psychosis
  • Unable or unwilling to complete follow-up during pregnancy and after delivery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu Hospital

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

Q

Qiang Shu, Dr.

CONTACT

Y

Yunfei Guo, Bachelor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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