Clinical characteristics and prognosis of acute stroke in pregnancy and puerperium (ASPP) patients and their offspring: a retrospective, observational, nationwide, multicenter study protocol

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BACKGROUND: Previous studies on the risk factors and prognosis of acute stroke in pregnancy and puerperium (ASPP) mainly used European and American national healthcare databases, lacking detailed patient-level data and precise event timing. AIM: (1) To identify the risk factors and prognostic factors for ASPP, (2) to assess the risk of recurrent stroke, particularly during subsequent pregnancies, and (3) to evaluate offspring prognosis. DESIGN: This study is a retrospective, observational, nationwide, multicenter research project planned to include 400 ASPP patients from 36 centers across 22 provinces in China, from 2015 to 2024. ASPP is defined as acute ischemic or hemorrhagic stroke during pregnancy or within 6 weeks postpartum, confirmed by neuroimaging. Two matched groups will be included for comparison: 400 pregnant/puerperal participants without a stroke history and 400 nonpregnant/puerperal participants with a recent stroke, matched by age and/or stroke etiology. METHODS: All participants will be followed up through telephone interviews. The initial follow-up is scheduled to take place between December 2024 and February 2025. The follow-up phase will consist of three rounds, each lasting 3 months and conducted every 3 years. Primary outcomes include unfavorable functional outcomes (mRS > 2 or EQ-5D index score < 0.7) at follow-up for Aim 1, recurrent strokes (neuroimaging-confirmed) for Aim 2, and neonatal asphyxia (Apgar scoring) and future development (ASQ-3) of offspring for Aim 3. DISCUSSION: The ASPP study is the first nationwide multicenter study to systematically evaluate the risk factors, prognosis, and risk of recurrent stroke in ASPP patients, particularly during subsequent pregnancies. This research may offer new insights into the long-term impacts of pregnancy-related stroke. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06527807).

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