Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium

NCT ID: NCT06527807

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy-associated or Puerperium-associated Acute Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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ASPP

Patients with acute stroke in pregnancy or puerperium

No interventions assigned to this group

Pregnant/Puerperal Non-Stroke

Pregnant or puerperal participants without any history of stroke

No interventions assigned to this group

Non-Pregnant Stroke

Non-pregnant or non-puerperal participants with a recent acute stroke event

No interventions assigned to this group

Eligibility Criteria

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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.


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.

2\. Cohort Study on Offspring Outcomes:


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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role collaborator

Baotou Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Jiangyin People's Hospital

OTHER

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of University of Science and Technology of China

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Hainan Medical University

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Tianjin Huanhu Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Xinxiang Central Hospital

OTHER

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

Binzhou Medical University

OTHER

Sponsor Role collaborator

Chongqing Medical University

OTHER

Sponsor Role collaborator

Tibetan Second People's Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xingju Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Jizong Zhao, MD

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zihan Yin, MD

Role: CONTACT

+8613718234402

Zhongji Zhang, MD

Role: CONTACT

+8613901318591

Facility Contacts

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Zihan Yin, MD

Role: primary

References

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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 in pregnancy and puerperium (ASPP) patients and their offspring: a retrospective, observational, nationwide, multicenter study protocol. Chin Neurosurg J. 2025 Jun 4;11(1):11. doi: 10.1186/s41016-025-00396-5.

Reference Type DERIVED
PMID: 40468421 (View on PubMed)

Other Identifiers

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KY2024-180-01

Identifier Type: -

Identifier Source: org_study_id

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