Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Pregnancy Related Clinical Trial

Official title:

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976465
• Other study ID #: SLE with Pregnancy QiluH
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Qilu Hospital of Shandong University
• Contact: Qiang Shu, Dr.
• Phone: 0086-0531-82169654
• Email: shuqiang[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Pregnancy Related
• Systemic Lupus Erythematosus

Intervention

Drug:
• Anticoagulation
Drug: Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ Aspirin 100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response to 32 weeks of pregnancy. 75mg po, once per day (Qd) to 34 weeks of pregnancy. 50mg po, once per day (Qd) to 36 weeks of pregnancy. Other Names: Asp Low molecular weight heparin Enoxaparin 40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response. Other Names: LMWH
• Without Anticoagulation
Drug: Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ

Locations

Country	Name	City	State
China	Qilu Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Percentage of all patients that lead to live birth after 28 weeks of gestation	After 28 weeks of gestation]
Secondary	Early miscarriage	Spontaneous pregnancy loss within 10 weeks of gestation	within 10 weeks of gestation]
Secondary	Intrauterine deaths	Spontaneous pregnancy loss after 10 weeks of gestation	after 10 weeks of gestation
Secondary	Stillbirth	Spontaneous pregnancy loss after 20 weeks of gestation	after 20 weeks of gestation
Secondary	Intrauterine growth retardation (IUGR)	weight below the 10th percentile for the gestational age	between 28 and 37 weeks of gestation
Secondary	Number of participants with low amniotic fluid during pregnancy	the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy	during pregnancy#an average of 10 months
Secondary	Number of participants with abnormal S / D values during pregnancy	the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy	during pregnancy#an average of 10 months