PEARLE Study

STUDY BASICS

Are you over 34 weeks pregnant and plan to deliver your baby at UPMC Magee-Womens Hospital? You may qualify for a research study designed to find out if an investigational device called the Jada™ System can control postpartum hemorrhage (excessive bleeding after delivery). You will only receive the Jada intervention in this study in the rare event that you experience postpartum hemorrhage.

STUDY PURPOSE

Postpartum hemorrhage (also called PPH) is when a woman has excessive blood loss after delivering a baby. Currently available treatments for PPH include uterine massage, medications, blood transfusions, and surgery, but these interventions can have unwanted side effects and are not always effective. Although PPH is uncommon, it is difficult to predict who will develop the condition because most women have no known risk factors.

 

The purpose of this research study is to find out if an investigational new device called the Jada™ System can control abnormal bleeding faster than other available options. Jada is a tool placed in the uterus after delivery that works by using gentle suction to contract the uterus and stop the bleeding. Jada is considered investigational because the Food and Drug Administration (FDA) has not approved it for sale.

COULD THIS STUDY BE RIGHT FOR YOU?

• More than 34 weeks pregnant
• Plan to deliver your baby at UPMC Magee-Womens Hospital

WHAT PARTICIPANTS CAN EXPECT

Women who plan to deliver at UPMC Magee-Womens Hospital can be evaluated before their delivery to find out if they are eligible for this research study, but only women who experience postpartum hemorrhage will receive the Jada intervention. Participants who are interested and eligible will be asked to sign the informed consent form.

 

If you have postpartum hemorrhage, your doctor will do what is most appropriate for your care. First, the doctor will try medicines to try to stop the bleeding. If those medicines don’t work and the doctor decides that you are still a good candidate for the study, the doctor will proceed with using the Jada System. Once inserted, the device will remain in place until the doctor believes it can be removed. If Jada is not effective, your doctor will pursue alternative treatments.

 

If you have postpartum hemorrhage after delivery and the Jada system is used, and if you also complete a 6-week office visit, you will be compensated $100.