Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium

Recruiting

• Conditions: Pregnancy-associated or Puerperium-associated Acute Stroke

• Registration Number: NCT06527807
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Study Start: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2024-10
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term modified Ranking Scale scores	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.
Apgar scores	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	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.
Recurrent strokes	At follow-up (assessed between July 2024 to October 2024)	Participants who suffer from recurrent stroke events confirmed by neuroimaging

Secondary Outcome Measures

Name	Time	Method
Short-term modified Ranking Scale scores	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.
Critical illness of offsprings	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
Strokes during subsequent pregnancies	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
Intrauterine death or stillbirth	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

Trial Locations

Locations (1)

Beijing Tiantan hospital; 🇨🇳 Beijing, Beijing, China