Intrauterine vacuum-induced hemorrhage control device controls bleeding for vaginal and cesarean deliveries

The application of an intrauterine vacuum-induced hemorrhage control device resulted in rapid and effective bleeding control for both vaginal and cesarean deliveries, as demonstrated by a real-world study's findings published in the journal Obstetrics & Gynecology. The FDA cleared the JADA system in August 2020 for managing abnormal postpartum uterine bleeding.

A team of researchers led by Dr Goffman and colleagues assessed the real-world effectiveness and safety of a U.S. FDA-cleared intrauterine vacuum-induced-hemorrhage control device for managing PPH (postpartum hemorrhage).

This study was conducted at 16 American centres between October 2020 and March 2022. The primary outcome was evaluated based on treatment success, which was defined as controlling bleeding without additional treatment or recurrence. The study also examined other outcomes, such as blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. The study evaluated treatment success and severe maternal morbidity by assessing blood loss before treatment and collected data on serious adverse events and adverse device effects to assess safety. The study summarized all outcomes by mode of delivery and treatment success by bleeding cause.

Key findings from the study are:

· 800 individuals were treated with the device ( (530 vaginal births, 270 cesarean births)

· 94.3% had uterine atony (alone or in combination with other causes).

· Median total blood loss at device insertion in vaginal and cesarean births was 1,050 mL and 1,600 mL, respectively.

· Across all bleeding causes, the treatment success rate vaginal and cesarean births was 92.5% and 83.7%, respectively. The Median indwelling time was 3.1 hours and 4.6 hours, respectively.

· In vaginal births and cesarean births, 14 SAEs (13 individuals) and 22 SAEs (21 individuals) were reported.

· Three SAEs were deemed possibly device or procedure-related.

· No uterine perforations or deaths were reported.

The FDA-cleared intrauterine vacuum-induced hemorrhage-control device effectively controlled bleeding in real-world settings for both vaginal and cesarean births. The safety profile was consistent with the registrational trial (NCT02883673), and no severe adverse device effects or SAEs were observed. This device serves as a crucial tool for managing life-threatening obstetric hemorrhage and may improve outcomes with timely utilization.

Reference:

Goffman et al. Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device. Obstetrics & Gynecology 142(5):p 1006-1016, November 2023. | DOI: 10.1097/AOG.0000000000005366