Bt-Cath® Balloon Tamponade Catheters

Background Information

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality and all women who carry a pregnancy beyond 20 weeks’ gestation are at risk for PPH and its complications, such as transfusion, hysterectomy, and infections. The entire blood volume of the pregnant woman circulates through the uterine arteries in 7 minutes! This means there is little time to waste when a PPH presents itself. After the placenta delivers, if there is excessive blood flow, then manual compression and assessing the uterine cavity for retained placenta are your first maneuvers, then medications, followed by the Balloon tamponade device if necessary. 

The pregnancy-related mortality ratio in the United States was 17.3 deaths per 100,000 live births in 2013. National statistics suggest that approximately 11.4% of these deaths are caused by PPH.  In industrialized countries, PPH usually ranks in the top 3 causes of maternal mortality, along with pulmonary embolism and hypertension (eclampsia). In the developing world, several countries have maternal mortality rates in excess of 1000 women per 100,000 live births, and World Health Organization statistics suggest that 60% of maternal deaths in developing countries are due to PPH, accounting for more than 100,000 maternal deaths per year.  A Practice Bulletin from the American College of Obstetricians and Gynecologists places the estimate at 140,000 maternal deaths per year or 1 woman every 4 minutes. 

PPH has many potential causes, but the most common is uterine atony,  which is failure of the uterus to contract and retract following delivery of the baby. PPH in a previous pregnancy is a major risk factor. In a randomized trial in the US, birthweight, labor induction and augmentation, chorioamnionitis, adherent placenta or retained placenta, magnesium sulfate use, and previous PPH were all positively associated with increased risk of PPH

Good evidence suggests that active management of the third stage of labor reduces the incidence and severity of PPH. Active management is the combination of (1) uterotonic administration (preferably oxytocin) immediately upon delivery of the baby, (2) early cord clamping and cutting, and (3) gentle cord traction with uterine counter traction when the uterus is well contracted (ie, Brandt-Andrews maneuver).

It is noteworthy that early administration of oxytocin (before placental delivery) did not increase the rate of retained placenta. Additionally, the trial showed trends toward a benefit for early administration of oxytocin, including a 25% reduction in PPH and a 50% reduction in the need for transfusion. These findings are consistent with the previous RCTs.

FAQs

Why is it necessary to have BT-Cath Balloon Available?

PPH is life-threatening so having all of your options available when resources are limited, such as blood products, uterotonics, and operating rooms, means having balloon tamponade devices in every delivery facility and for home use. Home deliveries are especially worrisome since patients do not have IVs in place. Therefore, having medications that can be given rectally and a balloon tmaponade device are crucial for each healthcare practitioner/ attendant.

Can the BT-Cath Balloon be used by inexperienced practitioners? 

Yes, almost anyone can learn how to use this device with minimal experience and you can use it without someone else’s help. It’s easy to use and provides a way to evaluate the amount of blood loss because it has an intrauterine drainage port that is flush with the fundus of the uterus.

Does the kit have everything I need to deploy the device?

No, you need a couple of NS IV bags, one for the device and the others in case you need IV access for excessive blood loss. Fluid resuscitation starts with normal saline or lactated ringers. 

How to Use

VideoBT-Cath® Video (utahmed.com)

1. Spike the IV Bag
2. Draw fluid from IV Bag into Syringe
3. Insert the balloon into the uterine cavity via the vagina or transabdominal.
4. If Cesarean Section, insert the balloon into the uterus and thread the fill tube out of the vagina to attach it to the syringe
5. Direct fluid from the syringe into the tube leading to the balloon; check valves will direct the fluid without the need for turning stopcocks
6. Continue to fill until the blood from the intrauterine drainage port is minimal. 
7. Leave in place until hemodynamically stable?  Or How long?
8. Consider slowly removing the saline from the balloon to assess if rebleeding occurs. 

References

1. Centers for Disease Control and Prevention. Reproductive Health: Pregnancy Mortality Surveillance System. Available athttps://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. June 29, 2017; Accessed: July 21, 2017.
2. WHO. Reducing the Global Burden: Postpartum Haemorrhage.Making Pregnancy Safer. 2007.
3. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage.Obstet Gynecol. 2006 Oct. 108(4):1039-47.
4. Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour.Cochrane Database Syst Rev. 2015 Mar 2. CD007412.Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage.Am J Obstet Gynecol. 2001 Oct. 185(4):873-7.
5. Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage.Am J Obstet Gynecol. 2001 Oct. 185(4):873-7. 
6. Weeks AD, Akinola OI, Amorim M, Carvalho B, Deneux-Tharaux C, Liabsuetrakul T, Meremikwu M, Miller S, Nabhan A, Nagai M, Wahabi H, Walker D. World Health Organization Recommendation for Using Uterine Balloon Tamponade to Treat Postpartum Hemorrhage. Obstet Gynecol. 2022 Mar 1;139(3):458-462. doi: 10.1097/AOG.0000000000004674. PMID: 35115478; PMCID: PMC8843394.
7. Kong MC, To WW. Balloon tamponade for postpartum haemorrhage: case series and literature review. Hong Kong Med J. 2013 Dec;19(6):484-90. doi: 10.12809/hkmj133873. Epub 2013 May 6. PMID: 23650196.
8. Kavak SB, Kavak EÇ, Demirel I, Ilhan R. Double-balloon tamponade in the management of postpartum hemorrhage: a case series. Ther Clin Risk Manag. 2014 Aug 2;10:615-20. doi: 10.2147/TCRM.S62574. PMID: 25120367; PMCID: PMC4128843.