Real-world use of a vacuum-induced hemorrhage-control device in births <34 weeks gestational age.

INTRODUCTION

The Jada System® is an FDA-cleared vacuum-induced hemorrhage-control device for the control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The instructions for use for Jada contain a warning stating that the safety and effectiveness of the Jada System in delivery at a gestational age less than 34 weeks or, if multiples, uterus judged less than 34 weeks size, have not been established. While the primary analysis of the RUBY registry, an 800 subject post-approval RWE study of the usage of Jada, included 50 individuals who had preterm births less than 34 weeks gestational age (wGA), the safety and outcomes were not evaluated specifically for less than 28 wGA and 28 to less than 34 wGA subgroups.

METHODS

We conducted a descriptive subgroup analysis of the real-world RUBY registry to assess the safety and effectiveness of Jada for postpartum hemorrhage management in preterm births less than 34 weeks (less than 28 wGA and 28 to less than 34 wGA). Of the 50 individuals treated, 24 had vaginal births and 26 had cesarean births.

RESULTS

Treatment success rates were 85.7% at less than 28 wGA (81.8% vaginal [9/11], 100% cesarean [3/3]) and 88.9% at 28 to less than 34 wGA (100% vaginal [13/13], 82.6% cesarean [19/23]). No maternal deaths, uterine perforations, device expulsions, or serious adverse device effects (ADEs) were reported in either subgroup. Two nonserious ADEs were reported in 1 individual (endometritis and bacterial vaginosis); 2 individuals required hysterectomy (1 vaginal, 1 cesarean).

CONCLUSION

Results for the less than 28 wGA and 28 to less than 34 wGA subgroups were consistent with the overall less than 34 wGA subgroup, which was previously shown to be consistent with births ≥34 wGA; however, continued attention to uterine size is warranted before device placement in births less than 34 wGA.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; NCT04995887.