Pregnancy-associated or Puerperium-associated Acute StrokeASPPNCT06527807
Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium
An observational study of Pregnancy-associated or Puerperium-associated Acute Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy-associated or Puerperium-associated Acute Stroke
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan hospital
Beijing, Beijing Municipality, 100070
Zihan Yin, MD, neuroyinzihan@foxmail.com
About this study
Official title: Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium: A Retrospective, Observational, Nationwide, Multicenter Study
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.
- Keywords
- Acute stroke, Pregnancy, Puerperium, Clinical characteristics, Prognosis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At follow-up (assessed between July 2024 to October 2024)
Recurrent strokes
Participants who suffer from recurrent stroke events confirmed by neuroimaging
Measured: 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.
Measured: 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.
Measured: At follow-up (assessed between July 2024 to October 2024)
Secondary outcomes (4)
Short-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.
Measured: At discharge (assessed up to 5 days)
Strokes during subsequent pregnancies
Participants who suffer from stroke events during any subsequent pregnancy
Measured: During subsequent pregnancies (assessed up to 5 days after the 6-week postpartum period of subsequent pregnancies)
Intrauterine death or stillbirth
Dead fetus in the uterus at any trimester of pregnancy, or birth of a dead infant after 28+1 gestational weeks
Measured: Before or at delivery
Critical illness of offsprings
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
Measured: At follow-up (assessed between July 2024 to October 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start31 Jul 2024
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-associated or Puerperium-associated Acute StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University, Affiliated Hospital of Nantong University, Baotou Central Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, Jiangyin People's 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, Lanzhou University Second Hospital, Tianjin Huanhu Hospital, Tianjin Medical University General Hospital, West China Hospital, Xiangya Hospital of Central South University, Xinxiang Central Hospital, Zhejiang Provincial People's Hospital, Binzhou Medical University, Chongqing Medical University, Tibetan Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- Xingju Liu, MD, Principal investigator, Beijing Tiantan HospitalJizong Zhao, MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527807
- Sponsor's protocol ID
- KY2024-180-01
- Acronym
- ASPP
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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.
PubMed 40468421
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium: A Retrospective, Observational, Nationwide, Multicenter Study
- ClinicalTrials.gov ID
- NCT06527807
- Acronym / sponsor ID
- ASPP / KY2024-180-01
- Keywords
- Acute stroke, Pregnancy, Puerperium, Clinical characteristics, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University, Affiliated Hospital of Nantong University, Baotou Central Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, Jiangyin People's 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, Lanzhou University Second Hospital, Tianjin Huanhu Hospital, Tianjin Medical University General Hospital, West China Hospital, Xiangya Hospital of Central South University, Xinxiang Central Hospital, Zhejiang Provincial People's Hospital, Binzhou Medical University, Chongqing Medical University, Tibetan Second People's Hospital
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- Patients or their legally acceptable representatives or relatives refuse follow-up;
- Patients missing critical baseline demographic, clinical or neuroimaging data.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Recurrent strokes
Time frame: At follow-up (assessed between July 2024 to October 2024)
Participants who suffer from recurrent stroke events confirmed by neuroimaging
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.
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.
4 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 40468421Zhang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingju Liu, MD principal investigator
Beijing Tiantan Hospital
Jizong Zhao, MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy-associated or Puerperium-associated Acute Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zihan Yin, MD (+8613718234402, neuroyinzihan@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term modified Ranking Scale scores (time frame: At follow-up (assessed between July 2024 to October 2024)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.