NCT04918524

The Clinical Features and Pregnancy Outcomes of CTD Patients

The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 126 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Connective tissue disease (CTD) is a common group of autoimmune diseases, mainly including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS) , and so on. APS is caused by autoimmune disorders that cause recurrent miscarriage, thrombosis, and thrombocytopenia, and often secondary to connective tissue diseases such as SLE. Undifferentiated connective tissue disease (UCTD) is currently considered to be an independent disease in the classification of CTD. And women of childbearing age who suffer UCTD is more common than that in other definite CTDs. Therefore, the impact of the disease flare and the influence of medicine on pregnancy and lactation are important for these patients who may suffer high-risk of abnormal pregnance.

Detailed description

Objective: To study the risk factors of poor pregnancy outcomes in CTD 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 CTD 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.

Conditions

• Connective Tissue Diseases
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Prednisone	5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
DRUG	Hydroxychloroquine	100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2018-09-11
• Primary completion: 2025-06-30
• Completion: 2026-12-31
• First posted: 2021-06-09
• Last updated: 2023-11-18

Locations

1 site across 1 country: China