NCT06527807

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 21, 2024

Last Update Submit

August 5, 2024

Conditions

Pregnancy-associated or Puerperium-associated Acute Stroke

Keywords

Acute strokePregnancyPuerperiumClinical characteristicsPrognosis

Outcome Measures

Primary Outcomes (4)

  • Long-term modified Ranking Scale scores

    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.

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

  • Recurrent strokes

    Participants who suffer from recurrent stroke events confirmed by neuroimaging

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

  • Apgar scores

    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.

    At 1 minutes, 5 minutes and 10 minutes after delivery

  • Age & Stages Questionnaires scores

    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.

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

Secondary Outcomes (4)

  • Short-term modified Ranking Scale scores

    At discharge (assessed up to 5 days)

  • Strokes during subsequent pregnancies

    During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)

  • Intrauterine death or stillbirth

    Before or at delivery

  • Critical illness of offsprings

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

Other Outcomes (1)

  • Length of hospitalization

    Between admission and discharge (assessed up to 5 days)

Study Arms (3)

ASPP

Patients with acute stroke in pregnancy or puerperium

Pregnant/Puerperal Non-Stroke

Pregnant or puerperal participants without any history of stroke

Non-Pregnant Stroke

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

  • 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 in pregnancy and puerperium (ASPP) patients and their offspring: a retrospective, observational, nationwide, multicenter study protocol. Chin Neurosurg J. 2025 Jun 4;11(1):11. doi: 10.1186/s41016-025-00396-5.

    PMID: 40468421DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xingju Liu, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

  • Jizong Zhao, MD

    Beijing Tiantan Hospital

    STUDY CHAIR

Central Study Contacts

Zihan Yin, MD

CONTACT

+8613718234402neuroyinzihan@foxmail.com

Zhongji Zhang, MD

CONTACT

+8613901318591zzj0202@outlook.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2024

First Posted

July 30, 2024

Study Start

July 31, 2024

Primary Completion

October 1, 2024

Study Completion

June 1, 2025

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)