The Clinical Features and Pregnancy Outcomes of CTD Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Live birth rate [Срок оценки: After 28 weeks of gestation]

Вторичные конечные точки (12)

• Early fetal loss [Срок оценки: within 10 weeks of gestation]
• Late fetal loss [Срок оценки: after 10 weeks of gestation]
• Stillbirth [Срок оценки: after 20 weeks of gestation]
• Preterm delivery [Срок оценки: between 28 and 37 weeks of gestation]
• Low-weight birth [Срок оценки: after 28 weeks of gestation]
• Premature rupture of membranes [Срок оценки: after 28 weeks of gestation]
• Placental abruption [Срок оценки: after 28 weeks of gestation]
• Fetal growth retardation (FGR) [Срок оценки: after 12 weeks of gestation]
• Number of participants with low amniotic fluid during pregnancy [Срок оценки: after 12 weeks of gestation]
• Number of participants with abnormal S / D values during pregnancy [Срок оценки: after 12 weeks of gestation]
• Number of participants with placental hematoma during pregnancy [Срок оценки: during pregnancy, an average of 10 months]
• Eclampsia [Срок оценки: after 20 weeks of gestation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Women who meet any of the following criteria will be excluded from the study:

1.Any known etiology of previous pregnancy loss:

• Known paternal, maternal or embryo chromosome abnormality.
• Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase);
• hyperprolactinemia; diabetes mellitus; other hypothalamic pituitary-adrenal axis abnormality
• Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.Vaginal infection.
• 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:

• Past history of digestive ulcers or upper gastrointestinal hemorrhage.
• Past history of malignancy.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Qilu Hospital — Цзинань

Идентификаторы

NCT: NCT04918524 · CTD with Pregnancy QiluH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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