Clinical trial NCT06527807: Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium
Official title: Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium: A Retrospective, Observational, Nationwide, Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy-associated or Puerperium-associated Acute Stroke
Keywords: Acute stroke
Pregnancy
Puerperium
Clinical characteristics
Prognosis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Jiangnan University
name: Affiliated Hospital of Nantong University
name: Baotou Central Hospital
name: First Affiliated Hospital of Harbin Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Jiangyin People's Hospital
name: Qianfoshan Hospital
name: RenJi Hospital
name: Second Affiliated Hospital of Soochow University
name: Second Hospital of Shanxi Medical University
name: Shanxi Bethune Hospital
name: Shenzhen Second People's Hospital
name: The Affiliated Hospital of Qingdao University
name: The First Affiliated Hospital of Nanchang University
name: The First Affiliated Hospital of University of Science and Technology of China
name: The First Affiliated Hospital of Zhengzhou University
name: The Second Affiliated Hospital of Hainan Medical University
name: Lanzhou University Second Hospital
name: Tianjin Huanhu Hospital
name: Tianjin Medical University General Hospital
name: West China Hospital
name: Xiangya Hospital of Central South University
name: Xinxiang Central Hospital
name: Zhejiang Provincial People's Hospital
name: Binzhou Medical University
name: Chongqing Medical University
name: Tibetan Second People's Hospital
First posted: 2024-07-30
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

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.

Primary outcomes:
measure: Long-term modified Ranking Scale scores
timeFrame: At follow-up (assessed between July 2024 to October 2024)
measure: Recurrent strokes
timeFrame: At follow-up (assessed between July 2024 to October 2024)
measure: Apgar scores
timeFrame: At 1 minutes, 5 minutes and 10 minutes after delivery
measure: Age & Stages Questionnaires scores
timeFrame: At follow-up (assessed between July 2024 to October 2024)
Secondary outcomes:
measure: Short-term modified Ranking Scale scores
timeFrame: At discharge (assessed up to 5 days)
measure: Strokes during subsequent pregnancies
timeFrame: During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)
measure: Intrauterine death or stillbirth
timeFrame: Before or at delivery
measure: Critical illness of offsprings
timeFrame: At follow-up (assessed between July 2024 to October 2024)
Other outcomes:
measure: Length of hospitalization
timeFrame: Between admission and discharge (assessed up to 5 days)
Locations:
city: Beijing
country: China
facility: Beijing Tiantan hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Xingju Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Jizong Zhao, MD
role: STUDY_CHAIR
References: