Morbidity and mortality related to postpartum hemorrhage (PPH) are often preventable if caught early, but the persistent rise in PPH-associated morbidity illustrates the need for new and innovative treatments, wrote Dena Goffman, MD, of New York-Presbyterian/Columbia University Irving Medical Center, New York, and colleagues.
New York-Presbyterian/Columbia University Irving Medical Center
Dr. Dena Goffman
The device, known as the Jada System, was cleared by the Food and Drug Administration for management of abnormal postpartum uterine bleeding or postpartum hemorrhage (PPH) in August 2020 and showed safety and effectiveness in a registrational study of 106 patients, the researchers said.
In a postmarket registry medical record review known as RUBY (Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage with the Jada System), the researchers examined data collected from Oct. 8, 2020, to March 31, 2022, at 16 centers in the United States. The findings were published in Obstetrics & Gynecology.
The study population included all individuals treated with an intrauterine vacuum-induced hemorrhage control device; of these, 530 were vaginal births and 270 were cesarean births. A total of 94.3% had uterine atony, alone or in conjunction with other causes of bleeding. The median maternal age was 30.3 years; approximately 60% and 53% of patients in the vaginal and cesarean groups were White, and approximately 43% and 49% of patients in the two groups, respectively, were nulliparous.
The median blood loss at the time of device insertion was 1,250 mL in vaginal births and 1,980 mL in cesarean births, and the median time from delivery of the placenta to device insertion was 31 minutes and 108 minutes in the two groups, respectively.
The primary endpoint was treatment success, defined as control of bleeding after device insertion, with no escalation of treatment or recurrence of bleeding after the initial bleeding control and device removal.
Treatment success was achieved in 92.5% of vaginal births and 83.7% of cesarean births, and in 95.8% and 88.2%, respectively, among patients with isolated uterine atony. The median insertion time was 3.1 hours for vaginal births and 4.6 hours for cesarean births.
The safety profile was similar to that in the registrational trial and adverse effects were those expected in patients with PPH, the researchers noted.
A total of 14 SAEs were reported in 13 patients with vaginal births, and 22 SAEs were reported in 21 patients with cesarean births. Of these, three were identified as possibly related to the device or procedure (two cases of endometritis in the vaginal birth group and one case of hemorrhagic shock in the cesarean group); no uterine perforations of deaths were reported during the study.
The study was limited by several factors including the use of data mainly from academic centers, which could limit generalizability, and by the use of a mix of estimated and quantitative reporting of blood loss, the researchers noted. Other limitations include the inability to make direct comparisons to other treatments for PPH.
However, the results confirm the safety and efficacy of the device in a real-world setting and support its use as an important new tool in the management of PPH and reducing maternal morbidity and mortality, they concluded.
Two companies were involved in the study; Alydia Health contributed to the concept, design, and analysis, and Organon contributed to data analysis and reviewed the manuscript.
Dr. Goffman disclosed research support from Organon and Alydia Health, as well as serving as a speaker for Haymarket and PRIME PPH education and for Laborie, participation in the Cooper Surgical Obstetrical Safety Council, and serving as an editor for UpToDate. Several coauthors disclosed relationships with multiple companies including Organon and Alydia Health.