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The Clinical Features and Pregnancy Outcomes of CTD Patients

NCT04918524 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Connective Tissue Diseases
  • Pregnancy Related

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Xiaoyun Yang, Dr. · Qilu Hospital of Shandong University

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2025-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04918524 on ClinicalTrials.gov