Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium: A Retrospective, Observational, Nationwide, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Recurrent strokes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients or their legally acceptable representatives or relatives refuse follow-up;
- •Patients missing critical baseline demographic, clinical or neuroimaging data.
- •Cohort Study on Offspring Outcomes:
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •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.
结局指标
主要结局
Recurrent strokes
时间窗: At follow-up (assessed between July 2024 to October 2024)
Participants who suffer from recurrent stroke events confirmed by neuroimaging
Long-term modified Ranking Scale scores
时间窗: At follow-up (assessed between July 2024 to October 2024)
The modified Ranking Scale (mRS) scores of ASPP and other comparison participants evaluated by specialists. The mRS scores range from 0 to 6, with higher scores indicating worse outcomes.
Apgar scores
时间窗: At 1 minutes, 5 minutes and 10 minutes after delivery
Apgar scores of newborns evaluated by specialists. Apgar scores range from 0 to 10, with higher scores indicating better outcomes. Apgar score 8-10 is considered as no asphyxia, 4-7 is considered as mild asphyxia, 0-3 is considered as severe asphyxia.
Age & Stages Questionnaires scores
时间窗: At follow-up (assessed between July 2024 to October 2024)
Age \& Stages Questionnaires, Third Edition (ASQ-3) scores of offsprings via online self-evaluation. ASQ-3 is divided into 5 subdomains. Scores of each subdomain range from 0 to 60, with higher scores indicating better outcomes.
次要结局
- Short-term modified Ranking Scale scores(At discharge (assessed up to 5 days))
- Critical illness of offsprings(At follow-up (assessed between July 2024 to October 2024))
- Strokes during subsequent pregnancies(During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies))
- Intrauterine death or stillbirth(Before or at delivery)