Qilu Hospital
Jinan, Shandong, 250012, China
Location status: Recruiting
NCT Number: NCT04976465
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.
Interested in participating?
Request Info20 year–45 year
Female
Interventional
Phase 1
Jinan, Shandong, 250012, China
Location status: Recruiting
Objective: To study the risk factors of poor pregnancy outcomes in SLE patients, and evaluate impact of different therapies on the maternal and fetal health. Methods: Our department and Shanghai Gothic Network Technology Co., Ltd. jointly established the chronic disease management of SLE patients during pregnancy and lactation by using Smart System of Disease Management#SSDM#. With this platform#patients in pregnancy can consult with rheumatologists face to face and follow-up regularly.
Follow-up: Consultation and followup will be scheduled every 4 weeks from confirmed pregnancy until delivery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
≥ 20uu/ L) in follicular stage;
Drug:
Other Names: HCQ
Other Names: Asp
Other Names: LMWH
Drug:
Other Names: HCQ
Time frame: After 28 weeks of gestation]
Percentage of all patients that lead to live birth after 28 weeks of gestation
Time frame: within 10 weeks of gestation]
Spontaneous pregnancy loss within 10 weeks of gestation
Time frame: after 10 weeks of gestation
Spontaneous pregnancy loss after 10 weeks of gestation
Time frame: after 20 weeks of gestation
Spontaneous pregnancy loss after 20 weeks of gestation
Time frame: between 28 and 37 weeks of gestation
weight below the 10th percentile for the gestational age
Time frame: during pregnancy#an average of 10 months
the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy
Time frame: during pregnancy#an average of 10 months
the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy
Contact information is provided by the study sponsor or research team.
Qiang Shu, Dr.
CONTACT
Yunfei Guo, Bachelor
CONTACT
Qilu Hospital of Shandong University
Other
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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