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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 45
Healthy Volunteers: f
View:

• Women who meet the following inclusion criteria will be eligible to participate in the study:

‣ Age between 20-45 years;

⁃ Diagnosed with APS: patients meet the Sydney classification criteria;

⁃ Diagnosed with UCTD: at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-extractable nuclear antigen (ENA) antibodies, anti-doublestranded DNA (ds-DNA) antibody, antiphospholipid antibody(aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting connective tissue disease(CTD) , while not fulfilling any classification criteria of a defined CTD.

⁃ Participate voluntarily in this study, willing to use medication and follow-up according to treatment plan, and sign informed consent.

Locations
Other Locations
China
Qilu Hospital
RECRUITING
Jinan
Contact Information
Primary
Qiang Shu, Dr.
shuqiang@sdu.edu.cn
0086-0531-82169654
Backup
Shuting Li
leeshuting1994@163.com
0086-0531-82169654
Time Frame
Start Date: 2018-09-11
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 126
Treatments
The Antiphospholipid syndrome (APS)
The cohort includes that patients who meet the proposed Sydney criteria.
Undifferentiated connective tissue disease (UCTD)
The cohort includes the patients who are diagnosed with UCTD: at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-extractable nuclear antigen (ENA) antibodies, anti-doublestranded DNA (ds-DNA) antibody, antiphospholipid antibodies (aPL), and non-criteria aPL (NC-aPL), with at least one symptoms or signs suggesting CTD ,while not fulfilling any classification criteria of a defined CTD.
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov