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Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device
Dena Goffman1, Kara M Rood, Angela Bianco
1New York-Presbyterian/Columbia University Irving Medical Center and the Icahn School of Medicine at Mount Sinai, New York, and the Long Island Jewish Medical Center, New Hyde Park, New York; The Ohio State University-Wexner Medical Center and OhioHealth, Columbus, and the Women's Health Institute, Cleveland Clinic, and Case Western Reserve University, University Hospitals Cleveland, Cleveland, Ohio; Ochsner Health, New Orleans, Louisiana; the West Virginia University School of Medicine and Charleston Area Medical Center, Charleston, West Virginia; The Mother Baby Center at Abbott Northwestern Hospital, Minneapolis, Minnesota; ChristianaCare Health System, Newark, Delaware; Loma Linda University Children's Hospital, Loma Linda, and Alydia Health Inc, Menlo Park, California; the University of Utah Health, Salt Lake City, Utah; Organon & Co., Jersey City, New Jersey; and the University of Pittsburgh Medical Center-Magee Women's Hospital, Pittsburgh, Pennsylvania.
This study shows that an FDA-cleared intrauterine vacuum device effectively controls postpartum hemorrhage (PPH) in real-world settings. The device demonstrated a high treatment success rate with an acceptable safety profile for both vaginal and cesarean births.
Area of Science:
- Obstetrics and Gynecology
- Medical Devices
- Hemorrhage Control
Background:
- Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality worldwide.
- Effective and safe management strategies are crucial for improving obstetric outcomes.
- Existing treatments may have limitations, necessitating novel interventions.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of an FDA-cleared intrauterine vacuum-induced hemorrhage control device for PPH management.
- To assess treatment success rates, blood loss, and severe maternal morbidity associated with the device.
- To analyze safety outcomes, including serious adverse events (SAEs) and adverse device effects.
Main Methods:
- An observational, postmarket registry study involving 16 US centers.
- Medical records of 800 individuals treated with the device for PPH were reviewed.
- Effectiveness outcomes included treatment success, blood loss, and time to control; safety outcomes included SAEs and adverse device effects.
Main Results:
- High treatment success rates were observed: 92.5% for vaginal births and 83.7% for cesarean births.
- The device demonstrated rapid bleeding control, with median indwelling times of 3.1 hours (vaginal) and 4.6 hours (cesarean).
- Serious adverse events were infrequent, with only 0.4% deemed possibly related to the device or procedure; no uterine perforations or deaths were reported.
Conclusions:
- The intrauterine vacuum-induced hemorrhage control device is effective and safe for managing PPH in real-world obstetric settings.
- The device offers a valuable new tool for clinicians to improve outcomes in life-threatening obstetric hemorrhage.
- Timely utilization of this device can potentially enhance maternal safety and reduce PPH-related morbidity.
