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Идёт набор NCT04976465

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Фаза I С лечением Systemic Lupus Erythematosus Pregnancy Related

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Anticoagulation, Without Anticoagulation.
Кому может быть актуально
Состояния в реестре: Systemic Lupus Erythematosus, Pregnancy Related. Базовые параметры: 20 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy: A Real World Study

Обзор

Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Since SLE patients usually have disease activity during pregnancy and postpartum, and a variety of maternal and fetal diseases are closely related to SLE, it is very important to monitor the disease activity and drug treatment of SLE patients during pregnancy.

Подробное описание

Objective: To study the risk factors of poor pregnancy outcomes in SLE 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 SLE 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 Anticoagulation
    Drug: 1. Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred 2. Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ 3. 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. Oth
  • Препарат Without Anticoagulation
    Drug: 1. Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred 2. Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Other Names: HCQ

Первичные конечные точки

  • Live birth rate [Срок оценки: After 28 weeks of gestation]]
Вторичные конечные точки (6)
  • Early miscarriage [Срок оценки: within 10 weeks of gestation]]
  • Intrauterine deaths [Срок оценки: after 10 weeks of gestation]
  • Stillbirth [Срок оценки: after 20 weeks of gestation]
  • Intrauterine growth retardation (IUGR) [Срок оценки: between 28 and 37 weeks of gestation]
  • Number of participants with low amniotic fluid during pregnancy [Срок оценки: during pregnancy#an average of 10 months]
  • Number of participants with abnormal S / D values during pregnancy [Срок оценки: during pregnancy#an average of 10 months]

Критерии участия

Критерии включения

  • Patients diagnosed with systemic lupus erythematosus (SLE) (ACR criteria, 1997);
  • Pregnant women aged 20-45 years old;
  • Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.

Критерии исключения

  • The cause of previous abortion was known:
  • Known chromosomal abnormalities in the parent, maternal or embryo.

\- Page 3 of 4 \[DRAFT\] -• Endocrine dysfunction of pregnant women: luteal dysfunction; Polycystic ovarian syndrome; Ovarian premature failure (FSH

≥ 20uu/ L) in follicular stage;

  • Hyperprolactinemia thyroid disease; Other hypothalamic pituitary adrenal axis abnormalities in diabetes mellitus.
  • Abnormal anatomy of pregnant women: abnormal uterus; Asherman syndrome; The uterine fibrosis of cervical insufficiency is more than 5 cm. Vaginal infection.
  • Any known serious heart disease, liver, kidney, blood or endocrine disease.
  • Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
  • Allergic to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin.
  • The history of the disease is as follows:
  • There was a history of peptic ulcer or upper gastrointestinal bleeding in the past.
  • The past history of malignant tumor.
  • The past history of epilepsy or psychosis.
  • Women who disagree or cannot complete the follow-up during pregnancy and after delivery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Qilu Hospital — Цзинань

Идентификаторы

NCT: NCT04976465 · SLE with Pregnancy QiluH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗