Treatment of a Pregnant Patient Using Thrombolytics Use of Thrombolytics in Pregnancy
Hanife Karakaya, MD1*, Assoc. Prof. Ayşe Güler, MD2, Prof. Dr. Hadiye Şirin, MD, PhD2
1Uşak Training and Research Hospital , Neurology Department, Turkey
²Ege University Faculty of Medicine, Neurology Department, Turkey
*Corresponding author
Hanife Karakaya, Uşak Training and Research Hospital , Neurology Department, Turkey.
DOI: 10.55920/JCRMHS.2025.11.001503
Abstract
IV rTPA is classified as a category C drug during pregnancy. This study reports the administration of the treatment to a patient with acute ischemic stroke at 12 weeks of gestation. A 28-year-old woman, 12 weeks pregnant, presented to the emergency department with motor aphasia and muscle strength graded at 2/5. Her NIHSS score was 12, and the time window for thrombolytic therapy was deemed appropriate. Due to a prior mechanical valve replacement (MVR), Magnetic Resonance Imaging (MRI) was contraindicated; therefore, a cranial computed tomography (CT) scan was performed after obtaining informed consent from the patient and her family. The patient's ASPECTS score was 8. Intravenous rTPA was administered after obtaining informed consent. The patient exhibited significant clinical improvement, with her 24-hour NIHSS score decreasing to 2. Upon discharge, her modified Rankin Disability Scale (mRDS) score was 0. A gynecologist evaluated the patient, and no abnormalities were detected during the fetal assessment. As a result, pregnancy termination was not advised. Although IV rTPA does not cross the placenta due to its high molecular weight, continuous fetal monitoring is recommended during its administration in pregnant patients. The 2016 American Heart Association (AHA) guidelines endorse the use of IV rTPA when the anticipated maternal benefit outweighs potential fetal risk. If indicated, the potential risks to the fetus should be assessed on a case-by-case basis, and the therapy may be considered, provided that emergency obstetric care is accessible.
Introduction
Alteplase is a thrombolytic agent indicated for the treatment of acute ischemic stroke, pulmonary embolism, and myocardial infarction (1). Intravenous Recombinant Tissue Plasminogen Activator (IV rTPA) is characterized by rapid serum clearance and a plasma half-life of approximately five minutes. It is classified as a Class 1A treatment with established efficacy in acute ischemic stroke (2). The most commonly reported adverse effect of IV rTPA is bleeding (3).
Although there are no definitive reports of maternal or fetal toxicity associated with IV rTPA, the drug is designated as a Category C agent for use during pregnancy by the FDA. Due to its large molecular weight (527 kDa), rTPA does not cross the placental barrier (4). Nevertheless, its potential complications during pregnancy primarily stem from hemorrhagic events. Therefore, the administration of IV rTPA in pregnant patients should be individualized, taking into account the gestational age and a careful evaluation of the benefit-to-risk ratio.
This report presents a case involving a pregnant patient treated with IV rTPA and discusses the relevant literature.
Case Report
A 28-year-old woman, 12 weeks pregnant and with a history of mitral valve replacement (MVR), presented to the emergency department with complaints of slurred speech and right-sided weakness. The patient had been receiving Clexane (2 × 0.6 cc daily), had one live birth, and experienced three first-trimester miscarriages. She reported no complications related to Clexane use during her pregnancies. Upon admission, she exhibited motor aphasia and right-sided muscle strength, graded at 2/5. Her National Institutes of Health Stroke Scale (NIHSS) score was 12, and the timing was appropriate for thrombolytic therapy. Due to the contraindication of Magnetic Resonance Imaging (MRI) associated with her prior MVR, Cranial Computed Tomography (CCT) was performed after obtaining informed consent from the patient and her relatives (Figure 1). The scan revealed an Alberta Stroke Program Early CT Score (ASPECTS) of 8.
The patient was treated with an intravenous recombinant tissue plasminogen activator (IV rTPA) after obtaining informed consent from both the patient and her relatives. Following the treatment, her NIHSS score improved from 12 to 9. Approximately one hour after the completion of thrombolytic therapy, the patient experienced vomiting, prompting an urgent Cranial Computed Tomography (CCT) scan to evaluate for potential hemorrhage. The scan revealed no acute pathology. Bedside echocardiography performed during the patient's admission to the intensive care unit (ICU) showed no evidence of intracardiac thrombus.
A gynecological examination conducted during the patient's ICU stay confirmed fetal well-being and showed no signs of placental hemorrhage. The patient continued to demonstrate clinical improvement, with her NIHSS score further decreasing to 2 at 24 hours post-treatment. A follow-up CCT performed at 24 hours identified an infarction in the left basal ganglia region. Anticoagulant therapy was resumed with Clexane (2 × 0.6 cc daily). Clinical monitoring revealed no complications, and the patient was transferred to the neurology department after three days of intensive care unit (ICU) care. Transesophageal echocardiography was scheduled, and the patient was referred to cardiology for further evaluation.
At discharge, the patient’s Modified Rankin Disability Scale (mRDS) score was 0, indicating no residual disability. A final gynecological assessment showed no fetal abnormalities, and the gynecologist did not recommend pregnancy termination.
Figure 1 :Cranial Computed Tomography (CCT) scans of the patient: a) Prior to thrombolytic therapy, b) 24 hours following thrombolytic therapy.
Discussion and Conclusion
Several similar cases have been documented in the literature. In one case study, thrombolytic therapy was administered to a five-week pregnant patient presenting with left-sided hemiplegia, resulting in favorable outcomes for both the mother and the fetus (5). Another study examined the use of IV rTPA in eight pregnant patients with acute ischemic stroke; seven patients recovered, with three undergoing therapeutic abortions, two experiencing miscarriages, and two achieving successful deliveries of healthy infants (6).
Although IV rTPA does not cross the placenta due to its high molecular weight (527 kDa), close fetal monitoring is recommended during its administration in pregnant patients. The most commonly reported adverse effect of the therapy is maternal hemorrhage, with an incidence rate of approximately 8% (5). While there have been no documented cases of teratogenicity, potential risks include uterine hemorrhage, placental abruption, and fetal demise (6,7).
Currently, no randomized controlled trials are investigating the use of IV rTPA in pregnant patients; the available literature consists primarily of case reports. According to the 2016 American Heart Association (AHA) inclusion-exclusion criteria, the use of thrombolytics during pregnancy is considered a relative contraindication. The guidelines recommend administering IV rTPA only when the anticipated maternal benefit outweighs potential risks to the fetus (2). In such cases, treatment decisions should be made on an individual basis, taking into account the gestational age and the availability of emergency obstetric interventions.
Ethics
Informed Consent: The authors declared that the patient signed an informed consent form.
Copyright Transfer Form: Copyright Transfer Form was signed by the authors.
Peer-review: Internally peer-reviewed.
Authorship Contributions:
Conflict of Interest: No conflict of interest was declared by the authors.
Financial Disclosure: The authors declared that this study received no financial support.
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