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RECRUITING
NCT04918524

The Clinical Features and Pregnancy Outcomes of CTD Patients

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

126

Start Date

2018-09-11

Completion Date

2026-12-31

Last Updated

2023-11-18

Healthy Volunteers

No

Interventions

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.

Locations (1)

Qilu Hospital

Jinan, Shandong, China