ABSTRACT
OBJECTIVE: To describe timing, antecedent events, and outcomes in pregnancy-related stroke (PAS). METHODS: Retrospective single-center cohort of all PAS within 42 days of delivery from September 2010 to May 2021. Data were abstracted from medical records. RESULTS: Among 51 500 births, we identified 91 cases of PAS, with a stroke rate of 177 per 100 000 births. Of all PAS, 62% (n = 56) were hemorrhagic, 56% (n = 51) occurred postpartum, 49% (n = 45) occurred in patients with hypertensive disorders of pregnancy (HDP), and 36% (n = 33) had surgical interventions. There were nine deaths, with a case fatality rate of 9.9%. Of the survivors (n = 82), 37 (45.1%) had residual deficits. Patients with HDP were more likely to have a postpartum stroke than those without HDP (crude relative risk 1.72, 95% confidence interval 1.16-2.55). Among patients with HDP, 89% had at least one severe range blood pressure (BP), with a peak systolic BP of 187.8 ± 27.9 mm Hg and a peak diastolic BP of 109.4 ± 18.4 mm Hg. There was no difference in presenting symptoms (P = 0.120), residual deficits (P = 0.609), or mortality (P = 0.739) between those with or without HDP. CONCLUSIONS: At a referral hospital, PAS was uncommon but was associated with a high mortality rate. An improved understanding of the modifiable risk factors is warranted to avert the sequelae of PAS.
Subject(s)
Hypertension, Pregnancy-Induced , Pre-Eclampsia , Stroke , Pregnancy , Female , Humans , Retrospective Studies , Stroke/epidemiology , Stroke/etiology , Blood Pressure , Risk Factors , Hypertension, Pregnancy-Induced/epidemiologyABSTRACT
OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.
