Study confirms efficacy of JADA against postpartum bleeding

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Amy Taneja, MD, discusses the results of the RUBY study, which evaluated the efficacy of the JADA device in women with postpartum bleeding and postpartum hemorrhage.

Contemporary OB/GYN:

Hi, I'm Celeste Krewson with Contemporary OBGYN and I'm here with Dr. Taneja to discuss a recent study on postpartum bleeding. Do you want to introduce yourself?

Amy Taneja, MD:

Sure. Thank you, Celeste, for having me today. My name is Amy Taneja, and I am a board-certified obstetrician-gynecologist who is working as the Director of Medical Affairs at Organon.

Contemporary OB/GYN:

So, to start with, could you discuss a bit about how postpartum bleeding impacts women's lives?

Taneja:

Sure, I'd be happy to do that. So traditionally, when we think about abnormal postpartum bleeding and postpartum hemorrhage, which is defined as abnormal bleeding that occurs after childbirth, we tend to think of it more as an issue that happens outside of the United States. But in reality, what we are noticing is that the rates of abnormal bleeding and postpartum hemorrhage are actually increasing right here in the United States. And so, it's important to recognize that these are potentially life threatening situations, they can have some serious consequences associated with them. And those consequences can range from anemia, sometimes requiring a blood transfusion, to perhaps requiring additional procedures to control bleeding, as well as a prolonged hospital stay. So, I think that's important to keep in mind when we are talking about ways to manage abnormal postpartum bleeding and postpartum hemorrhage.

Contemporary OB/GYN:

And why was this recent study conducted?

Taneja:

So, to give a little bit more background for the audience, when a physician is evaluating a patient who's experiencing a postpartum hemorrhage, they have to consider multiple potential causes. Although the most common of these causes is typically the situation where the uterus becomes fatigued, and it just doesn't contract well after delivery. With JADA, it works by using a low-level vacuum system to help stimulate the normal contraction process that we would expect to occur after delivery. JADA was cleared for use in the United States a couple of years ago, based upon our pivotal study, which showed that it worked in the majority of women to control bleeding and PPH. It was important to understand, outside of that controlled clinical trial environment, how it was used in the real world setting by healthcare professionals. So that's why we conducted the study called RUBY.

Contemporary OB/GYN:

And can you briefly give an overview of the study's results?

Taneja:

Certainly. So, RUBY is as I mentioned, a real-world study. There were some advantages of this particular study, from the standpoint that there were 800 women in the study, which was actually quite large for a device study. There were women studied who had cesarean sections as well as vaginal deliveries, and these women experienced all different blood loss levels. And what we found was that JADA was effective in the vast majority of women who experienced postpartum hemorrhage. It reinforced the results of our pivotal study.

Contemporary OB/GYN:

Were there any results that surprised you?

Taneja:

I would say, in my years of experience as an obstetrician gynecologist, in the real world setting, there can be so many factors or variables that can affect patient care and the overall clinical scenario. So really, it was just reassuring to see how consistent the RUBY results were when we compared it to the pivotal study. Certainly, we were optimistic that this would be the case. But in the end, those findings were really just reassuring overall.

Contemporary OB/GYN:

Yeah, that's great. We’re just about ready to wrap up, but is there anything you want to add first?

Taneja:

Well, I think at the end of the day, it's important to recognize that abnormal postpartum bleeding and postpartum hemorrhage is a serious condition. It is increasing in frequency here in the United States, and we know from our pivotal study that JADA was effective in managing these conditions. Now we have results from our real-world study that helps to reinforce that. And for my colleagues who are practicing in obstetrics and gynecology, I want them to keep in mind that this device is effective, and it's an important tool to have in your toolbox for managing postpartum hemorrhage.

Contemporary OB/GYN:

That’s all a great point. Thank you for speaking with me today.

Taneja:

Thank you so much for having me.

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