Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device

CONCLUSION: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04995887.PMID:37713322 | DOI:10.1097/AOG.0000000000005366

Source: Obstetrics and Gynecology - September 15, 2023 Category: OBGYN Authors: Dena Goffman Kara M Rood Angela Bianco Joseph R Biggio Paul Dietz Kelly Drake Erica Heilman Maeve Hopkins Monique De Four Jones Tyler Katz Courtney Martin Mona Prasad Marcela C Smid Kathryn D Wine Robert Ryan Candice Yong Patricia I Carney Hyagriv N Simha Source Type: research