Uterine Balloon Tamponade

Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality worldwide. It is an emergent situation which can quickly escalate and then require invasive surgical intervention.

According to ACOG:

“When treating postpartum hemorrhage, it is necessary to balance the use of conservative management techniques with the need to [timely] control the bleeding and achieve hemostasis.” (ACOG Practice Bulletin No. 76, Oct. 2006)

“When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after vaginal delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony.” (ACOG Practice Bulletin No. 76, Oct. 2006)

A systematic, stepwise approach to managing primary PPH includes the use of the BT-Cath® Balloon Tamponade Catheter. The advantages of using a balloon catheter for tamponade include timely utilization, ability to continuously monitor lost fluids, and less invasive removal procedure. The unique BT-Cath® features a soft silicone balloon that contours to the uterine wall. BT-Cath® is designed with check valves and is packaged with a bag-spike and two sterile syringes to aid in timely catheter utilization.

PRODUCT DESCRIPTION

BT-Cath® is a soft, silicone, dual lumen balloon tamponade catheter for managing postpartum hemorrhage (PPH).

FEATURES

• A soft balloon that is easy to insert, contours to the uterine wall, provides drainage near the fundus and does not require a surgical procedure to remove.
• A uterine drainage port that is flush with the top of the inflated balloon.
• A dual lumen catheter that allows infusion of saline to expand the balloon while providing uterine drainage to monitor the progression of hemostasis.
• Durable silicone components with optimal biocompatibility and strength.
• Two syringes to provide for uninterrupted infusion of saline for timely tamponade expansion.
• A bag spike and stopcock equipped with check valves for efficient saline infusion without the need to repeatedly manipulate a stopcock.

INDICATIONS

BT-Cath® is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.

CONTRAINDICATIONS

• Cervical cancer.
• Purulent infections in the vagina, cervix or uterus.
• Postpartum vaginal bleeding unaccompanied by uterine bleeding.
• Disseminated intravascular coagulation.
• Untreated uterine anomaly.
• Bleeding requiring surgical exploration (including hysterectomy) or angiographic embolization.
• Cases indicating hysterectomy.
• Pregnancy.
• A surgical site that would prohibit the device from effectively controlling the bleeding.

CLINICAL REFERENCE

— Dabelea V, Schultze PM, McDuffie RS Jr. Intrauterine balloon tamponade in the management of postpartum hemorrhage. Am J Perinatol. 2007 Jun;24(6):359-64. Epub 2007 Jun 13.
— Postpartum Hemorrhage. ACOG Practice Bulletin, No. 76—October 2006