Clinical Characteristics and Prognosis of Acute Stroke in Pregnancy and Puerperium: A Retrospective, Observational, Nationwide, Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy-associated or Puerperium-associated Acute Stroke
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Recurrent strokes
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary 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
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.
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.
Secondary Outcomes
- Short-term modified Ranking Scale scores(At discharge (assessed up to 5 days))
- Critical illness of offsprings(At follow-up (assessed between July 2024 to October 2024))
- 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)