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Recruiting NCT06527807

Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium

— Observational Pregnancy-associated or Puerperium-associated Acute Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnancy-associated or Puerperium-associated Acute Stroke. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 [Time frame: At follow-up (assessed between July 2024 to October 2024)]
  • Recurrent strokes [Time frame: At follow-up (assessed between July 2024 to October 2024)]
  • Apgar scores [Time frame: At 1 minutes, 5 minutes and 10 minutes after delivery]
  • Age & Stages Questionnaires scores [Time frame: At follow-up (assessed between July 2024 to October 2024)]
Secondary outcome measures (4)
  • Short-term modified Ranking Scale scores [Time frame: At discharge (assessed up to 5 days)]
  • Strokes during subsequent pregnancies [Time frame: During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)]
  • Intrauterine death or stillbirth [Time frame: Before or at delivery]
  • Critical illness of offsprings [Time frame: At follow-up (assessed between July 2024 to October 2024)]

Eligibility criteria

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

Inclusion criteria

  • Female patients ≥18 years of age;
  • 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

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

2\. Cohort Study on Offspring Outcomes:

Inclusion criteria

  • Female patients ≥18 years of age;
  • Patients in pregnancy or within 6 weeks postpartum;
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Beijing Tiantan hospital — Beijing

Publications

  • 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 PMID 40468421

Identifiers

NCT: NCT06527807 · KY2024-180-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗