LB05 - Real-world Utilization of an Intrauterine Vacuum-induced Hemorrhage-control Device

Friday, February 10, 2023

10:00 AM – 10:15 AM

Location: Room 3018, Moscone West, Level 3

Objective: Intrauterine vacuum-induced hemorrhage control device is a new tool in management of postpartum hemorrhage after being FDA-cleared in Aug 2020. The objective of this study was to report on real-world effectiveness and safety of this device.

Study Design: An observational, post-market registry chart review was conducted at 16 US centers selected for ability to readily collect data on device use (NCT04995887). We report baseline characteristics, treatment outcomes overall and by isolated uterine atony, and adverse events/device effects. The primary outcome, treatment success, was defined as device successfully controlling bleeding with no treatment escalation or bleeding recurrence. Data are presented by mode of delivery.

Results: From Oct 2020-Apr 2022, 800 individuals were treated with the device; 94.3% had uterine atony. Treatment success was 92.5% for vaginal births and 83.7% for cesarean births. In cases where uterine atony was the sole cause of bleeding (isolated uterine atony; n=307 vaginal, n=220 cesarean), treatment success was 95.8% for vaginal and 88.2% for cesarean births (Table 1). For vaginal births, mean indwelling time (insertion to removal) was 4.6 hours and bleeding recurred after device removal in 2.8% (Table 1). For cesarean births, mean indwelling time was 6.3 hours and 4.1% had bleeding recur (Table 1). Time to bleeding control was available in 49% of cases. In vaginal births (n=241), 73.8% (n=178) achieved bleeding control in ≤ 5 minutes. In cesarean births (n=151), 62.2% (n=94) achieved bleeding control in ≤ 5 minutes. Of the adverse events/device effects reported (Table 2), 3 serious events were deemed possibly related to the device or procedure [2 (0.4%) vaginal, 1 (0.4%) cesarean].

Conclusion: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was observed with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The adverse event profile was consistent with that observed in the registrational trial (NCT02883673). This device may help to decrease maternal morbidity and improve obstetric hemorrhage outcomes.

Primary & Presenting Author(s)

Dena Goffman, MD (she/her/hers)

Professor, Women's Health in Obstetrics & Gynecology; Vice Chair, Quality & Patient Safety
Columbia University Irving Medical Center
New York, New York, United States

Slides

Coauthor(s)

Kara M. Rood, MD

Ohio State University Wexner Medical Center
Delaware, Ohio, United States
AB

Angela Bianco, MD

Attending Physician
Mount Sinai Medical Center
New York, New York, United States
Joseph R. Biggio, Jr., MD,MSc

System Chair, Women's Services
Ochsner Health
New Orleans, Louisiana, United States
PD

Paul Dietz, MD

Associate Professor and Department Chief
West Virginia University School of Medicine and Charleston Area Medical Center
Charleston, West Virginia, United States
KD

Kelly Drake, MSN, RN

Clinical Program Specialist
The Mother Baby Center at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
EH

Erica Heilman, MD

Christiana Care Hospital System
Newark, Delaware, United States
Maeve Hopkins, MD

Associate Staff
Department of Maternal-Fetal Medicine, Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic
Rocky River, Ohio, United States
MD

Monique De Four Jones, MD

Associate Chief of Labor and Delivery; Associate Professor, Obstetrics and Gynecology
Zucker School of Medicine at Hofstra/Northwell
New York, New York, United States
TK

Tyler Katz, MD (she/her/hers)

Senior Attending Physician, OB/GYN
Case Western Reserve University School of Medicine
Cleveland, Ohio, United States
CM

Courtney Martin, DO

Loma Linda University
Loma Linda, California, United States
Mona Prasad, DO, MPH

Medical Director, Maternal Fetal Medicine
OhioHealth Physician Group
Columbus, Ohio, United States
Marcela C. Smid, MA, MD, MS

Assistant Professor
University of Utah Health
Salt Lake City, Utah, United States
KW

Kathryn Wine, MPH

Alydia Health
San Mateo, California, United States
RR

Robert Ryan, MS

Executive Director, Biostatistics
Organon & Co.
Jersey City, New Jersey, United States
CY

Candice Yong, PhD

Director, Outcomes Research
Organon & Co.
Jersey City, New Jersey, United States
PC

Patricia I. Carney, MD

Director, Medical Affairs
Organon & Co.
Jersey City, New Jersey, United States
Hyagriv Simhan, MD

Professor
University of Pittsburgh
Pittsburgh, Pennsylvania, United States