妊娠和产褥期急性卒中患者及其后代的临床特征和预后:一项回顾性、观察性、全国性、多中心研究方案

Q2 Medicine
Zhongji Zhang, Zihan Yin, Tong Liu, Xiaolin Zhang, Qihang Zhang, Junlin Lu, Long Mu, Yang Dong, Juning Liu, Yi Xiao, Yanming Chen, Chenyang Song, Zengguang Wang, Yuheng Liu, Wei Ding, Li Zhang, Huaizhang Shi, Jingtao Qi, Bin Tang, Fei Wang, Pin Guo, Yongjun Tang, Mingsheng Yu, Wenjian Zheng, Qinglong He, Jian Yu, Aihua Zhu, Dazhao Fang, Gang Li, Yu Bai, Yushuang Zhang, Jiaxi Li, Yuli Wang, Faliang Gao, Yonggang Ma, Yifan Liu, Li Ma, Bao Yang, Yahui Zhao, Xun Ye, Qian Zhang, Yan Zhang, Xingju Liu, Jizong Zhao
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引用次数: 0

摘要

背景:以往关于妊娠和产褥期急性卒中(ASPP)危险因素及预后的研究主要使用欧美国家卫生数据库,缺乏详细的患者层面数据和精确的事件时间。目的:(1)确定ASPP的危险因素和预后因素;(2)评估卒中复发的风险,特别是在随后的妊娠期间;(3)评估后代预后。设计:本研究是一项回顾性、观察性、全国性、多中心的研究项目,计划于2015年至2024年在中国22个省份的36个中心纳入400名ASPP患者。ASPP定义为妊娠期或产后6周内经神经影像学证实的急性缺血性或出血性中风。两个匹配组将被纳入比较:400名没有中风史的孕妇/产褥期参与者和400名最近中风的非孕妇/产褥期参与者,按年龄和/或中风病因匹配。方法:对所有参与者进行电话随访。最初的后续行动计划在2024年12月至2025年2月之间进行。后续阶段将包括三轮,每轮持续3个月,每3年进行一次。主要结局包括Aim 1随访时不良功能结局(mRS > 2或EQ-5D指数评分< 0.7),Aim 2随访时卒中复发(神经影像学证实),Aim 3随访时新生儿窒息(Apgar评分)和后代未来发育(ASQ-3)。讨论:ASPP研究是第一个全国性的多中心研究,系统地评估ASPP患者中风复发的危险因素、预后和风险,特别是在随后的怀孕期间。这项研究可能为妊娠相关中风的长期影响提供新的见解。试验注册:ClinicalTrials.gov (NCT06527807)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Clinical characteristics and prognosis of acute stroke in pregnancy and puerperium (ASPP) patients and their offspring: a retrospective, observational, nationwide, multicenter study protocol.

Clinical characteristics and prognosis of acute stroke in pregnancy and puerperium (ASPP) patients and their offspring: a retrospective, observational, nationwide, multicenter study protocol.

Clinical characteristics and prognosis of acute stroke in pregnancy and puerperium (ASPP) patients and their offspring: a retrospective, observational, nationwide, multicenter study protocol.

Background: Previous studies on the risk factors and prognosis of acute stroke in pregnancy and puerperium (ASPP) mainly used European and American national healthcare databases, lacking detailed patient-level data and precise event timing.

Aim: (1) To identify the risk factors and prognostic factors for ASPP, (2) to assess the risk of recurrent stroke, particularly during subsequent pregnancies, and (3) to evaluate offspring prognosis.

Design: This study is a retrospective, observational, nationwide, multicenter research project planned to include 400 ASPP patients from 36 centers across 22 provinces in China, from 2015 to 2024. ASPP is defined as acute ischemic or hemorrhagic stroke during pregnancy or within 6 weeks postpartum, confirmed by neuroimaging. Two matched groups will be included for comparison: 400 pregnant/puerperal participants without a stroke history and 400 nonpregnant/puerperal participants with a recent stroke, matched by age and/or stroke etiology.

Methods: All participants will be followed up through telephone interviews. The initial follow-up is scheduled to take place between December 2024 and February 2025. The follow-up phase will consist of three rounds, each lasting 3 months and conducted every 3 years. Primary outcomes include unfavorable functional outcomes (mRS > 2 or EQ-5D index score < 0.7) at follow-up for Aim 1, recurrent strokes (neuroimaging-confirmed) for Aim 2, and neonatal asphyxia (Apgar scoring) and future development (ASQ-3) of offspring for Aim 3.

Discussion: The ASPP study is the first nationwide multicenter study to systematically evaluate the risk factors, prognosis, and risk of recurrent stroke in ASPP patients, particularly during subsequent pregnancies. This research may offer new insights into the long-term impacts of pregnancy-related stroke.

Trial registration: ClinicalTrials.gov (NCT06527807).

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