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Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06527807
Acronym
ASPP
Enrollment
1200
Registered
2024-07-30
Start date
2024-07-31
Completion date
2025-06-30
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy-associated or Puerperium-associated Acute Stroke

Keywords

Acute stroke, Pregnancy, Puerperium, Clinical characteristics, Prognosis

Brief 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.

Interventions

None listed

Sponsors

Affiliated Hospital of Jiangnan University
CollaboratorOTHER
Affiliated Hospital of Nantong University
CollaboratorOTHER
Baotou Central Hospital
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
Jiangyin People's Hospital
CollaboratorOTHER
Qianfoshan Hospital
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Second Affiliated Hospital of Soochow University
CollaboratorOTHER
Second Hospital of Shanxi Medical University
CollaboratorOTHER
Shanxi Bethune Hospital
CollaboratorOTHER
Shenzhen Second People's Hospital
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
The First Affiliated Hospital of Nanchang University
CollaboratorOTHER
The First Affiliated Hospital of University of Science and Technology of China
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
The Second Affiliated Hospital of Hainan Medical University
CollaboratorOTHER
Lanzhou University Second Hospital
CollaboratorOTHER
Tianjin Huanhu Hospital
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
Xinxiang Central Hospital
CollaboratorOTHER
Zhejiang Provincial People's Hospital
CollaboratorOTHER
Binzhou Medical University
CollaboratorOTHER
Chongqing Medical University
CollaboratorOTHER
Tibetan Second People's Hospital
CollaboratorUNKNOWN
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Age & Stages Questionnaires scoresAt 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.
Long-term modified Ranking Scale scoresAt 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.
Recurrent strokesAt follow-up (assessed between July 2024 to October 2024)Participants who suffer from recurrent stroke events confirmed by neuroimaging
Apgar scoresAt 1 minutes, 5 minutes and 10 minutes after deliveryApgar 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.

Secondary

MeasureTime frameDescription
Intrauterine death or stillbirthBefore or at deliveryDead fetus in the uterus at any trimester of pregnancy, or birth of a dead infant after 28+1 gestational weeks
Critical illness of offspringsAt follow-up (assessed between July 2024 to October 2024)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
Short-term modified Ranking Scale scoresAt discharge (assessed up to 5 days)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.
Strokes during subsequent pregnanciesDuring subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)Participants who suffer from stroke events during any subsequent pregnancy

Other

MeasureTime frameDescription
Length of hospitalizationBetween admission and discharge (assessed up to 5 days)Time span of hospitalization as a resulting from stroke treatment

Countries

China

Contacts

Primary ContactZihan Yin, MD
neuroyinzihan@foxmail.com+8613718234402
Backup ContactZhongji Zhang, MD
zzj0202@outlook.com+8613901318591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026