Maternal and Fetal Safety Outcomes of Thrombolytics for Ischemic Stroke in Pregnancy

BACKGROUND AND OBJECTIVES: The safety of intravenous thrombolytics for ischemic stroke in pregnancy is largely unknown. We performed a systematic review to identify published use of thrombolytics for stroke during pregnancy, with the aim of assessing maternal and fetal safety outcomes. To provide additional safety data, we included cases of thrombolysis for deep vein thrombosis, mechanical valve thrombosis, and pulmonary embolism in pregnancy. METHODS: We used the PRISMA and MOOSE guidelines to conduct the review. We searched 3 databases (OVID Medline, EMBASE, Scopus) for studies published up to October 2025. We analyzed outcomes in a Bayesian aggregated case series to compare rates of adverse outcomes in our cohort with those in the general population. Elective termination and spontaneous abortion were grouped together, given that it was often difficult to determine whether complications of thrombolysis may have played a role in the decision for termination. RESULTS: We included 123 studies of 216 patients (median age 31 years) treated with thrombolytics during pregnancy, of whom 85 had ischemic stroke. Six of the 32 total fetal deaths were deemed likely to be causally related to thrombolytics (3 in stroke). The risk of miscarriage in our thrombolysis population was 12.4% higher (95% credible interval [CrI]: 2.6%, 23.2%) than published general pregnant population rates, and the risk of stillbirth was 5.9% higher (95% CrI: 1.6%, 12.7%). The proportion of pregnant patients with symptomatic intracerebral hemorrhage was similar between our pregnant cohort and young, nonpregnant patients receiving thrombolytics (risk difference -0.4%; 95% CrI: -0.8%, 2.7%). DISCUSSION: Thrombolytics were likely causally associated with a small minority of published cases of fetal death after thrombolysis in pregnancy. There was no signal of increased harm from thrombolysis to the mother, including similar rates of symptomatic intracerebral hemorrhage. In many cases, it was difficult to discern effects of thrombolytics on fetal outcomes from the effects of the disease itself; hence, our results should be interpreted with caution. Nonetheless, our findings broadly support the use of thrombolytics in otherwise-eligible pregnant patients but underscore the importance of the risk-benefit assessment in such patients. TRIAL REGISTRATION INFORMATION: The study protocol was pre-registered on PROSPERO (registration number: CRD42024605043).