Understanding acute stroke in pregnant women and new mothers

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

This study looks at how strokes affect pregnant women and new mothers, including their recovery and the health of their babies, to better understand the risks and outcomes.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Sex: Female
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06527807 on ClinicalTrials.gov

What this trial studies

This observational study aims to describe the clinical characteristics and prognosis of acute stroke associated with pregnancy and the puerperium. It will explore risk factors for acute stroke in pregnant women, compare recovery outcomes with controls, and evaluate the risk of recurrent strokes during subsequent pregnancies. Additionally, the study will assess the short-term and long-term developmental outcomes of offspring born to these patients. The research is divided into case-control and cohort studies to gather comprehensive data.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 and older who are either pregnant or within six weeks postpartum and consent to participate.

Not a fit: Patients who are not pregnant or postpartum, or those who refuse follow-up or consent, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding and management of acute stroke in pregnant women, leading to better outcomes for both mothers and their children.

How similar studies have performed: While there is limited data on this specific population, similar studies on stroke in pregnancy have shown promising insights into risk factors and outcomes.

Eligibility criteria

1\. Case-control Study and Cohort Study on Recurrent Stroke Risk:

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.

2\. 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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xingju Liu, MD — Beijing Tiantan Hospital
• Study coordinator: Zihan Yin, MD

Conditions: Pregnancy-associated or Puerperium-associated Acute Stroke, Acute stroke, Pregnancy, Puerperium, Clinical characteristics, Prognosis