Uterine balloon tamponade

Uterine balloon tamponade (UBT) is a non-surgical method of treating refractory postpartum hemorrhage. Once postpartum hemorrhage has been identified and medical management given (including agents such as uterotonics and tranexamic acid), UBT may be employed to tamponade uterine bleeding without the need to pursue operative intervention. Numerous studies have supported the efficacy of UBT as a means of managing refractory postpartum hemorrhage.[1][2][3][4][5][6][7][8] The International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO) recommend UBT as second-line treatment for severe postpartum hemorrhage.[9][10]

Uterine balloon tamponade
SpecialtyOBGYN

Method

Regardless of which device is used, all share the same basic components and method of application. The UBT generally consists of a balloon, a catheter or some form of tubing to inflate the balloon, and a syringe to inflate the balloon. Balloons range from home-grown interventions such as a condom or glove, to custom made silicone balloons. After performing uterine massage and evacuating the uterine cavity, the deflated balloon is inserted through the cervix into the uterine cavity in a semi-sterile fashion. Once positioned, the medical provider inflates the balloon, typically using saline, through the syringe and tubing, until bleeding slows or stops. A second, smaller balloon is sometimes included in UBT kits in order to secure the device inside the uterus. The patient should be monitored closely after insertion to observe for any further bleeding or clinical decompensation. If bleeding has ceased, balloons are left in place for anywhere from 24–36 hours in order to control postpartum hemorrhage, or until uterine contraction and subsequent expulsion of the device occurs. If bleeding is not abated using UBT, operative intervention such as B-lynch sutures or obstetric hysterectomy, should be pursued.

Devices

Various UBT devices are available. Each device varies in cost, reusability, and in the body of evidence supporting its efficacy. The list below is not exhaustive.

Condom-catheter

Condom-catheter uterine balloon tamponade devices are the least expensive and generally most accessible globally, as they are constructed from commonly available medical supplies including a condom and foley catheter.

ESM-UBT

The ESM-UBT, developed by the Vayu Global Health Foundation, was specifically designed for implementation in low-resource settings and costs a fraction compared to upwards of $300 USD for other commercially available devices. The FDA approved device[11] consists of a size 24 urinary catheter, condoms, o-rings, Luer‐lock one-way valve, an illustrated checklist, and a data collection card. Numerous studies support the efficacy of the ESM-UBT in controlling refractory postpartum hemorrhage,[12][13][14][15][16] and it has been endorsed by the International Federation of Gynecology and Obstetrics (FIGO) as second-line management for postpartum hemorrhage.[9]

The device is available under the trade name Dr. Burke's ESM-UBT Kit in India and Nepal.

Bakri

The Bakri balloon is a medical device invented by Dr. Younes Bakri. It features a 24 French, 54 cm-long, silicone catheter with a filling capacity of 500 mL. It has been shown to be an effective means of controlling postpartum hemorrhage.[17][18][19]

Ellavi

The Ellavi balloon is a medical device developed by PATH and Sinapi biomedical[20] It was also designed to be used in low-resource settings, and features a supply bag that provides vertical filling pressure of the balloon. The Ellavi UBT is free flow pressure controlled uterine balloon that allows intra-uterine balloon pressure control by adjusting the height of the supply bag and allows water to be expelled from the balloon when the uterus contracts. Two case series were conducted to assess feasibility and acceptance of physicians and midwives using the Ellavi UBT.[21][22]

Global usage

Postpartum hemorrhage is the leading cause of maternal mortality worldwide[23][24] In low-resource settings, timely access to surgical facilities may be limited by transport time to tertiary care. Uterine balloon tamponade provides a necessary option to tamponade bleeding while transport occurs to higher levels of care. In addition, UBT can treat severe postpartum hemorrhage and avoid the need for surgical intervention entirely. The ESM-UBT,[25] developed by the Vayu Global Health Foundation, has been shown to be a cost-effective and clinically-effective means of treating refractory postpartum hemorrhage in low-resource settings.[12][13][14][15][16]

References
  1. Revert, M; Cottenet, J; Raynal, P; Cibot, E; Quantin, C; Rozenberg, P (July 2017). "Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study". BJOG: An International Journal of Obstetrics & Gynaecology. 124 (8): 1255–1262. doi:10.1111/1471-0528.14382. PMID 27781401.
  2. Tindell, K; Garfinkel, R; Abu-Haydar, E; Ahn, R; Burke, Tf; Conn, K; Eckardt, M (January 2013). "Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review: UBT for treatment of PPH-a systematic review". BJOG: An International Journal of Obstetrics & Gynaecology. 120 (1): 5–14. doi:10.1111/j.1471-0528.2012.03454.x. PMID 22882240.
  3. Kaya, Bariş; Tuten, Abdullah; Daglar, Korkut; Misirlioglu, Mesut; Polat, Mesut; Yildirim, Yusuf; Unal, Orhan; Kilic, Gokhan Sami; Guralp, Onur (2014-01-01). "Balloon tamponade for the management of postpartum uterine hemorrhage". Journal of Perinatal Medicine. 42 (6): 745–753. doi:10.1515/jpm-2013-0336. ISSN 1619-3997. PMID 24663227. S2CID 207463932.
  4. Rathore, Asmita Muthal; Gupta, Sonali; Manaktala, Usha; Gupta, Sangeeta; Dubey, Chandan; Khan, Mumtaz (September 2012). "Uterine tamponade using condom catheter balloon in the management of non-traumatic postpartum hemorrhage: Condom balloon tamponade in PPH". Journal of Obstetrics and Gynaecology Research. 38 (9): 1162–1167. doi:10.1111/j.1447-0756.2011.01843.x. PMID 22540529. S2CID 25703455.
  5. Agarwal, Dr. Manju; Soni, Dr. Rakhee (2019-05-21). "Use of the Condom Catheter to Control the Massive Postpartum Hemorrhage". International Journal of Medical and Biomedical Studies. 3 (5). doi:10.32553/ijmbs.v3i5.250. ISSN 2589-8698.
  6. Georgiou, C (May 2009). "Balloon tamponade in the management of postpartum haemorrhage: a review". BJOG: An International Journal of Obstetrics & Gynaecology. 116 (6): 748–757. doi:10.1111/j.1471-0528.2009.02113.x. PMID 19432563. S2CID 20721973.
  7. Bakri, Y.N; Amri, A; Abdul Jabbar, F (August 2001). "Tamponade-balloon for obstetrical bleeding". International Journal of Gynecology & Obstetrics. 74 (2): 139–142. doi:10.1016/s0020-7292(01)00395-2. ISSN 0020-7292. PMID 11502292. S2CID 6336447.
  8. Doumouchtsis, Stergios K.; Papageorghiou, Aris T.; Arulkumaran, Sabaratnam (August 2007). "Systematic Review of Conservative Management of Postpartum Hemorrhage: What to Do When Medical Treatment Fails". Obstetrical & Gynecological Survey. 62 (8): 540–547. doi:10.1097/01.ogx.0000271137.81361.93. ISSN 0029-7828. PMID 17634155. S2CID 21383129.
  9. International Federation of Gynecology and Obstetrics (January 13, 2020). "Save Mothers, Stop PPH". FIGO. Retrieved April 11, 2020.
  10. World Health Organization (2012). "WHO recommendations for the prevention and treatment of postpartum haemorrhage" (PDF). World Health Organization. Retrieved April 11, 2020.
  11. "Life-Saving Healthcare Device Granted FDA Approval". www.newswire.com. Retrieved 2020-04-11.
  12. Burke, Thomas F.; Danso-Bamfo, Sandra; Guha, Moytrayee; Oguttu, Monica; Tarimo, Vincent; Nelson, Brett D. (October 2017). "Shock progression and survival after use of a condom uterine balloon tamponade package in women with uncontrolled postpartum hemorrhage". International Journal of Gynecology & Obstetrics. 139 (1): 34–38. doi:10.1002/ijgo.12251. PMID 28675419. S2CID 6099836.
  13. Pendleton, Anna Alaska; Natarajan, Abirami; Ahn, Roy; Nelson, Brett D.; Eckardt, Melody J.; Burke, Thomas F. (April 2016). "Emergency hysterectomy for uncontrolled postpartum hemorrhage may be averted through uterine balloon tamponade in Kenya and Senegal". International Journal of Gynecology & Obstetrics. 133 (1): 124. doi:10.1016/j.ijgo.2015.09.006. PMID 26797194. S2CID 40079587.
  14. Burke, Tf; Ahn, R; Nelson, Bd; Hines, R; Kamara, J; Oguttu, M; Dulo, L; Achieng, E; Achieng, B; Natarajan, A; Maua, J (August 2016). "A postpartum haemorrhage package with condom uterine balloon tamponade: a prospective multi-centre case series in Kenya, Sierra Leone, Senegal, and Nepal". BJOG: An International Journal of Obstetrics & Gynaecology. 123 (9): 1532–1540. doi:10.1111/1471-0528.13550. PMID 26223284.
  15. Mvundura, Mercy; Kokonya, Donald; Abu-Haydar, Elizabeth; Okoth, Eunice; Herrick, Tara; Mukabi, James; Carlson, Lucas; Oguttu, Monica; Burke, Thomas (May 2017). "Cost-effectiveness of condom uterine balloon tamponade to control severe postpartum hemorrhage in Kenya". International Journal of Gynecology & Obstetrics. 137 (2): 185–191. doi:10.1002/ijgo.12125. PMID 28190262. S2CID 41693539.
  16. Herrick, Tara; Mvundura, Mercy; Burke, Thomas F.; Abu-Haydar, Elizabeth (December 2017). "A low-cost uterine balloon tamponade for management of postpartum hemorrhage: modeling the potential impact on maternal mortality and morbidity in sub-Saharan Africa". BMC Pregnancy and Childbirth. 17 (1): 374. doi:10.1186/s12884-017-1564-5. ISSN 1471-2393. PMC 5683546. PMID 29132342.
  17. Diemert, Anke; Ortmeyer, Gerhard; Hollwitz, Bettina; Lotz, Manuela; Somville, Thierry; Glosemeyer, Peter; Diehl, Werner; Hecher, Kurt (January 2012). "The combination of intrauterine balloon tamponade and the B-Lynch procedure for the treatment of severe postpartum hemorrhage". American Journal of Obstetrics and Gynecology. 206 (1): 65.e1–65.e4. doi:10.1016/j.ajog.2011.07.041. ISSN 0002-9378. PMID 22000893.
  18. Lo, Anderson; St. Marie, Peter; Yadav, Parul; Belisle, Elizabeth; Markenson, Glenn (2017-05-19). "The impact of Bakri balloon tamponade on the rate of postpartum hysterectomy for uterine atony". The Journal of Maternal-Fetal & Neonatal Medicine. 30 (10): 1163–1166. doi:10.1080/14767058.2016.1208742. ISSN 1476-7058. PMID 27364858. S2CID 3446700.
  19. Darwish, Atef M.; Abdallah, Mohamed M.; Shaaban, Omar M.; Ali, Mohammed K.; Khalaf, Mohamed; Sabra, Ali Mohamed A. (2017-03-08). "Bakri balloon versus condom-loaded Foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial". The Journal of Maternal-Fetal & Neonatal Medicine. 31 (6): 747–753. doi:10.1080/14767058.2017.1297407. ISSN 1476-7058. PMID 28274173. S2CID 19360538.
  20. "ellavi.com". Retrieved 2020-04-11.
  21. Theron, Gerhard (2018). "Management of postpartum haemorrhage with free-flow pressure controlled uterine balloon". Int J Gynecol Obstet. 142 (3): 371–373. doi:10.1002/ijgo.12533. PMID 29779208. S2CID 29156843.
  22. Johnson M, Theron G, De Villiers C, Smit N, De Villiers A, Koekemoer N.  Postpartum haemorrhage managed with Ellavi UBT free flow pressure controlled uterine balloons by midwives. 40th Conference on Priorities in Perinatal Care in Southern Africa, March 2020
  23. World Health Organization (2013). "6.16 Postpartum Hemorrhage" (PDF). Retrieved April 11, 2020.
  24. FIGO. "PPH leading to unnecessary deaths". FIGO. Retrieved April 11, 2020.
  25. "ESM-UBT". Vayu Global Health Foundation. Retrieved 2020-04-11.
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