Intrauterine Vacuum-Induced Hemorrhage-Control Device for Ra
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Postpartum hemorrhage is the leading cause of maternal mortality worldwide and is responsible for 25% of maternal deaths from obstetric causes. Moreover, the problem is growing, particularly in the United States, where rates of severe maternal morbidity and transfusions have increased despite commensurately increasing utilization rates of first- and second-line postpartum hemorrhage treatment modalities. Many important efforts have been developed to address these trends, notably comprehensive safety bundles inclusive of recognition and prevention of abnormal postpartum bleeding, the readiness with improved training and transfusion protocols, and robust quality reporting, and yet there have been few innovative approaches to treat abnormal postpartum bleeding or postpartum hemorrhage before morbidity occurs.

Uterine atony causes up to 80% of all postpartum hemorrhages. After most deliveries, constriction of the uterine vasculature occurs when contraction of the interlacing muscle fibers of the myometrium control bleeding after placental delivery. The Jada System (novel intrauterine vacuum-induced hemorrhage-control device) was specifically designed to offer rapid treatment by applying a low-level intrauterine vacuum to facilitate the physiologic forces of uterine contractions to constrict myometrial blood vessels and achieve hemostasis. The device was evaluated in a prior feasibility study outside the United States that showed promise as a rapid treatment for abnormal postpartum uterine bleeding or postpartum hemorrhage. The study reported herein was conducted to evaluate the effectiveness and safety of the intrauterine vacuum-induced hemorrhage-control device to control abnormal postpartum uterine bleeding or postpartum hemorrhage in a larger patient population.

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% 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%).

In conclusion, the intrauterine vacuum-induced hemorrhage-control device offers a therapeutic modality that may be considered early in the treatment of abnormal postpartum uterine bleeding or postpartum hemorrhage. Given the speed with which the device has been demonstrated to control abnormal bleeding and postpartum hemorrhage, it is likely to offer benefits to the patient and family, the clinical team, and the health care system overall. This study demonstrates that the intrauterine vacuum-induced hemorrhage-control device might fill an essential treatment need as we strive to decrease rates of severe maternal morbidity and mortality and improve maternal outcomes.

Source: https://journals.lww.com/greenjournal/Fulltext/2020/11000/Intrauterine_Vacuum_Induced_Hemorrhage_Control.4.aspx
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