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NCT Number: NCT06527807

Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Tiantan hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Zihan Yin, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. Long-term modified Ranking Scale scores

    Time frame: At 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.

  2. Recurrent strokes

    Time frame: At follow-up (assessed between July 2024 to October 2024)

    Participants who suffer from recurrent stroke events confirmed by neuroimaging

  3. Apgar scores

    Time frame: At 1 minutes, 5 minutes and 10 minutes after delivery

    Apgar 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.

  4. Age & Stages Questionnaires scores

    Time frame: At 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.

Secondary outcomes

  1. Short-term modified Ranking Scale scores

    Time frame: At 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.

  2. Strokes during subsequent pregnancies

    Time frame: During 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

  3. Intrauterine death or stillbirth

    Time frame: Before or at delivery

    Dead fetus in the uterus at any trimester of pregnancy, or birth of a dead infant after 28+1 gestational weeks

  4. Critical illness of offsprings

    Time frame: At 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

Other outcomes

  1. Length of hospitalization

    Time frame: Between admission and discharge (assessed up to 5 days)

    Time span of hospitalization as a resulting from stroke treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongji Zhang, MD

CONTACT

[email protected]

+8613901318591

Zihan Yin, MD

CONTACT

[email protected]

+8613718234402

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ASPP

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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