A therapeutic innovation against postpartum hemorrhage

in collaboration with

Dr Odile Bagot (Gynecologist-obstetrician)

In a study that was presented at the annual meeting of the Society for Maternal-Fetal Medicine (SMFM) held from February 6 to 11 in San Francisco in the United States, researchers presented their bleeding control device postpartum intrauterine.

Uterine atony: one of the main causes of bleeding

The researchers studied the reliability, effectiveness and safety of their device through a study in real conditions. To do this, they tested their technique on 800 women who gave birth in 16 hospitals in the United States, between October 2020 and April 2022.

Among these patients 94.3% had uterine atony, ie a lack of contractions of the muscle of the uterus. It is the most common cause of postpartum hemorrhage and occurs when the uterus does not contract enough to stop bleeding after childbirth.

Treatment of bleeding in more than eight out of ten cases

The researchers found that the device successfully treated postpartum hemorrhage in 92.5% of vaginal deliveries, and in 83.7% of cesarean deliveries.

In addition, for a subgroup of women, the duration of bleeding was measured:

• For vaginal deliveries, bleeding was controlled in 73.8% of patients in five minutes or less;
• In cesarean deliveries, bleeding was controlled in 62.2% of patients in five minutes or less.

Finally, the authors of this work report that the average time between the moment the device was inserted into the patient’s uterus and the moment it was removed was 4.6 hours for vaginal births and 6.3 hours for cesarean births.

A system cleared by the FDA in 2020

The system, dubbed JADA by the researchers, was authorized by the US Food and Drug Administration in August 2020 after the presentation of a study demonstrating that the device was “safe and effective” for the treatment of postpartum hemorrhage. “In our study, we wanted to assess the safety and effectiveness of the device in the real world for a larger number of patients for vaginal deliveries and for cesarean sections” explains the study’s lead author, Dena Goffman, a professor in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York City.

“What emerges from our study is that this device worked in real conditions. It worked quickly and was very effective in controlling postpartum hemorrhage after vaginal and cesarean delivery in a high proportion of patients. Additionally, the device was safe and should only remain in place for a few hours after placement, allowing for a smoother postpartum care experience.”.