The Clinical Features and Pregnancy Outcomes of CTD Patients
NCT ID: NCT04918524
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
126 participants
OBSERVATIONAL
2018-09-11
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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The Antiphospholipid syndrome (APS)
The cohort includes that patients who meet the proposed Sydney criteria.
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
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.
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.
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.
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
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.
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.
Interventions
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Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with APS: patients meet the Sydney classification criteria;
3. 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.
4. Participate voluntarily in this study, willing to use medication and follow-up according to treatment plan, and sign informed consent.
Exclusion Criteria
1.Any known etiology of previous pregnancy loss:
1. Known paternal, maternal or embryo chromosome abnormality.
2. Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase);
3. hyperprolactinemia; diabetes mellitus; other hypothalamic pituitary-adrenal axis abnormality
4. Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.Vaginal infection.
5. Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:
2\. Any active infection: Active infection including V aricella zostervirus(VZV), human immunodeficiency virus (HIV), Human papillomavirus (HPV),syphilis or tuberculosis.
3\. Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.
4.Disease history as follows:
1. Past history of digestive ulcers or upper gastrointestinal hemorrhage.
2. Past history of malignancy.
3. Past history of epilepsia or psychotic disorders.
5.Women have been diagnosed with Systemic lupus erythematosus
6\. Women who disagree or cannot complete pregnancy and follow-up after delivery.
20 Years
45 Years
FEMALE
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Qiang Shu
Chief Physician
Principal Investigators
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Xiaoyun Yang, Dr.
Role: STUDY_DIRECTOR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTD with Pregnancy QiluH
Identifier Type: -
Identifier Source: org_study_id
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