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Идёт набор NCT06527807

Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium

— Наблюдательное Pregnancy-associated or Puerperium-associated Acute Stroke

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pregnancy-associated or Puerperium-associated Acute Stroke. Базовые параметры: Без ограничений · 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

Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium: A Retrospective, Observational, Nationwide, Multicenter Study

Обзор

The objectives of this study are: (1) to describe the detailed clinical characteristics and prognosis of ASPP patients in order to explore the risk factors of ASPP, and to compare the short-term and long-term functional recovery outcomes between them and their controls; (2) to evaluate the risk of recurrent stroke, particularly during subsequent pregnancies, in ASPP patients; (3) to assess the short-term and long-term outcomes of their offsprings and their future development status. This study is divided into three parts. The first part is a case-control study to explore the risk factors of ASPP and the predictors of the prognosis of ASPP patients. The second part is a cohort study to evaluate the impact of ASPP on the risk of recurrent stroke. The third part is a cohort study to assess the impact of ASPP on the short-term and long-term outcomes of their offsprings by comparing the offsprings of ASPP patients with the offsprings of non-ASPP participants.

Первичные конечные точки

  • Long-term modified Ranking Scale scores [Срок оценки: At follow-up (assessed between July 2024 to October 2024)]
  • Recurrent strokes [Срок оценки: At follow-up (assessed between July 2024 to October 2024)]
  • Apgar scores [Срок оценки: At 1 minutes, 5 minutes and 10 minutes after delivery]
  • Age & Stages Questionnaires scores [Срок оценки: At follow-up (assessed between July 2024 to October 2024)]
Вторичные конечные точки (4)
  • Short-term modified Ranking Scale scores [Срок оценки: At discharge (assessed up to 5 days)]
  • Strokes during subsequent pregnancies [Срок оценки: During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)]
  • Intrauterine death or stillbirth [Срок оценки: Before or at delivery]
  • Critical illness of offsprings [Срок оценки: At follow-up (assessed between July 2024 to October 2024)]

Критерии участия

1\. Case-control Study and Cohort Study on Recurrent Stroke Risk:

Критерии включения

  • Female patients ≥18 years of age;
  • Patients or their legally acceptable representatives or relatives agree to collect personal information for this study and sign an oral or online written informed consent.

Критерии исключения

  • Patients or their legally acceptable representatives or relatives refuse follow-up;
  • Patients missing critical baseline demographic, clinical or neuroimaging data.

2\. Cohort Study on Offspring Outcomes:

Критерии включения

  • Female patients ≥18 years of age;
  • Patients in pregnancy or within 6 weeks postpartum;
  • Patients or their legally acceptable representatives or relatives agree to collect personal information for this study and sign an oral or online written informed consent.

Критерии исключения

  • Patients or their legally acceptable representatives or relatives refuse follow-up;
  • Patients missing critical baseline demographic, clinical or neuroimaging data;
  • Patients whose offsprings have congenital malformation or inborn error of metabolism;
  • Patients with complications which may affect cerebral blood flow supply, such as amniotic fluid embolism, in pregnancy;
  • Patients whose family members other than the parents and siblings of their offsprings have a history of severe mental illness, such as mental retardation, autism and schizophrenia;
  • Patients undergo acute myocardial infarction in pregnancy;
  • Patients undergo non-spontaneous stroke events due to other causes, such as cerebral infarction or hemorrhage caused by surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Beijing Tiantan hospital — Пекин

Публикации

  • Zhang Z, Yin Z, Liu T, Zhang X, Zhang Q, Lu J, Mu L, Dong Y, Liu J, Xiao Y, Chen Y, Song C, Wang Z, Liu Y, Ding W, Zhang L, Shi H, Qi J, Tang B, Wang F, Guo P, Tang Y, Yu M, Zheng W, He Q, Yu J, Zhu A, Fang D, Li G, Bai Y, Zhang Y, Li J, Wang Y, Gao F, Ma Y, Liu Y, Ma L, Yang B, Zhao Y, Ye X, Zhang Q, Zhang Y, Liu X, Zhao J; ASPP Study Group. Clinical characteristics and prognosis of acute stroke PMID 40468421

Идентификаторы

NCT: NCT06527807 · KY2024-180-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗