Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium
NCT Number: NCT06527807
Acronym: ASPP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy-associated or Puerperium-associated Acute Stroke
Sponsor: Beijing Tiantan Hospital
Collaborators: Affiliated Hospital of Jiangnan University|Affiliated Hospital of Nantong University|Baotou Central Hospital|First Affiliated Hospital of Harbin Medical University|First Affiliated Hospital Xi'an Jiaotong University|Jiangyin People's Hospital|Qianfoshan Hospital|RenJi Hospital|Second Affiliated Hospital of Soochow University|Second Hospital of Shanxi Medical University|Shanxi Bethune Hospital|Shenzhen Second People's Hospital|The Affiliated Hospital of Qingdao University|The First Affiliated Hospital of Nanchang University|The First Affiliated Hospital of University of Science and Technology of China|The First Affiliated Hospital of Zhengzhou University|The Second Affiliated Hospital of Hainan Medical University|The Second Hospital of Lanzhou University|Tianjin Huanhu Hospital|Tianjin Medical University General Hospital|West China Hospital|Xiangya Hospital of Central South University|Xinxiang Central Hospital|Zhejiang Provincial People's Hospital|Binzhou Medical University|Chongqing Medical University|Tibetan Second People's Hospital
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2025-06
Locations: Beijing Tiantan hospital, Beijing, Beijing, 100070, China

Summary:
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.

Primary Outcome Measures: Long-term modified Ranking Scale scores, 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., At follow-up (assessed between July 2024 to October 2024)|Recurrent strokes, Participants who suffer from recurrent stroke events confirmed by neuroimaging, At follow-up (assessed between July 2024 to October 2024)|Apgar scores, 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., At 1 minutes, 5 minutes and 10 minutes after delivery|Age & Stages Questionnaires scores, 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., At follow-up (assessed between July 2024 to October 2024)
Secondary Outcome Measures: Short-term modified Ranking Scale scores, 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., At discharge (assessed up to 5 days)|Strokes during subsequent pregnancies, Participants who suffer from stroke events during any subsequent pregnancy, During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)|Intrauterine death or stillbirth, Dead fetus in the uterus at any trimester of pregnancy, or birth of a dead infant after 28+1 gestational weeks, Before or at delivery|Critical illness of offsprings, Offsprings requiring hospitalization due to diagnosed diseases within 15 years after birth, including neurological diseases (e.g. epilepsy, cerebral palsy), cardiovascular diseases (e.g. congenital heart disease), gastrointestinal diseases (e.g. necrotizing enterocolitis), respiratory diseases (e.g. allergic asthma), urological diseases (e.g. hypospadias), hematological and immunological diseases and other major diseases, At follow-up (assessed between July 2024 to October 2024)
Other Outcome Measures: Length of hospitalization, Time span of hospitalization as a resulting from stroke treatment, Between admission and discharge (assessed up to 5 days)