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

Capital Medical University

Status: Enrolling

Conditions: Pregnancy-associated or Puerperium-associated Acute Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT06527807

KY2024-180-01

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

3. 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.

Trial design

1,200 participants in 3 patient groups

ASPP

Description:

Patients with acute stroke in pregnancy or puerperium

Pregnant/Puerperal Non-Stroke

Description:

Pregnant or puerperal participants without any history of stroke

Non-Pregnant Stroke

Description:

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