Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium (ASPP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy-associated or Puerperium-associated Acute Stroke

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Zihan Yin, MD; Phone Number: +8613718234402; Email: neuroyinzihan@foxmail.com
• Study Contact Backup: Name: Zhongji Zhang, MD; Phone Number: +8613901318591; Email: zzj0202@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Zihan Yin, MD; Email: neuroyinzihan@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ASPP patients and non-ASPP participants during 2010-2024 will be included. For the first part of this study, ASPP patients will be included as cases. This study will also include pregnant or puerperal participants without any history of stroke and non-pregnant or non-puerperal participants with a recent acute stroke event as non-ASPP participants. Non-ASPP participants will be included at Beijing Tiantan Hospital.

ASPP patients are defined as patients undergo acute stroke events in pregnancy or within 6 weeks postpartum, with the evidence of cerebral infarction or hemorrhage confirmed by neuroimaging corresponding to their symptoms. Considered events will be ischemic stroke, hemorrhagic stroke (including primary and secondary (e.g. due to vascular malformations or systemic disorders) intracerebral hemorrhage and subarachnoid hemorrhage), cerebral venous thrombosis, cerebral artery dissection or central nervous system vasculitis. Transient ischemic stroke will be excluded.

Description

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

Inclusion Criteria:

1. Female patients ≥18 years of age;
2. 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:

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

2. Cohort Study on Offspring Outcomes:

Inclusion Criteria:

1. Female patients ≥18 years of age;
2. Patients in pregnancy or within 6 weeks postpartum;
3. 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:

1. Patients or their legally acceptable representatives or relatives refuse follow-up;
2. Patients missing critical baseline demographic, clinical or neuroimaging data;
3. Patients whose offsprings have congenital malformation or inborn error of metabolism;
4. Patients with complications which may affect cerebral blood flow supply, such as amniotic fluid embolism, in pregnancy;
5. 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;
6. Patients undergo acute myocardial infarction in pregnancy;
7. Patients undergo non-spontaneous stroke events due to other causes, such as cerebral infarction or hemorrhage caused by surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ASPP; Patients with acute stroke in pregnancy or puerperium
Pregnant/Puerperal Non-Stroke; Pregnant or puerperal participants without any history of stroke
Non-Pregnant Stroke; Non-pregnant or non-puerperal participants with a recent acute stroke event

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Length of hospitalization	Time span of hospitalization as a resulting from stroke treatment	Between admission and discharge (assessed up to 5 days)

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; Xiangya Hospital of Central South University; RenJi Hospital; West China Hospital; Affiliated Hospital of Jiangnan University; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; Chongqing Medical University; The First Affiliated Hospital of Zhengzhou University; Qianfoshan Hospital; Tianjin Medical University General Hospital; Shenzhen Second People's Hospital; Second Affiliated Hospital of Soochow University; Zhejiang Provincial People's Hospital; The First Affiliated Hospital of University of Science and Technology of China; Jiangyin People's Hospital; First Affiliated Hospital of Harbin Medical University; Second Hospital of Shanxi Medical University; Affiliated Hospital of Nantong University; Baotou Central Hospital; Tianjin Huanhu Hospital; Xinxiang Central Hospital; Shanxi Bethune Hospital; The Second Affiliated Hospital of Hainan Medical University; Binzhou Medical University; The Second Hospital of Lanzhou University; Tibetan Second People's Hospital
• Investigators: Study Chair: Jizong Zhao, MD, Beijing Tiantan Hospital; Principal Investigator: Xingju Liu, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Pregnancy; Acute stroke; Clinical characteristics; Puerperium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KY2024-180-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No