Uterine balloon tamponade

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Uterine balloon tamponade
Specialty OBGYN

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]

Contents

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.[ citation needed ]

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.[ citation needed ]

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]

Related Research Articles

Dilationand curettage (D&C) refers to the dilation of the cervix and surgical removal of part of the lining of the uterus or contents of the uterus by scraping and scooping (curettage). It is a gynecologic procedure used for diagnostic and therapeutic purposes, and is the most commonly used method for first-trimester miscarriage or abortion.

<span class="mw-page-title-main">Hysterectomy</span> Surgical removal of the uterus

Hysterectomy is the surgical removal of the uterus and cervix. Supracervical hysterectomy refers to removal of the uterus while the cervix is spared. These procedures may also involve removal of the ovaries (oophorectomy), fallopian tubes (salpingectomy), and other surrounding structures. The term “partial” or “total” hysterectomy are lay-terms that incorrectly describe the addition or omission of oophorectomy at the time of hysterectomy. These procedures are usually performed by a gynecologist. Removal of the uterus renders the patient unable to bear children and has surgical risks as well as long-term effects, so the surgery is normally recommended only when other treatment options are not available or have failed. It is the second most commonly performed gynecological surgical procedure, after cesarean section, in the United States. Nearly 68 percent were performed for conditions such as endometriosis, irregular bleeding, and uterine fibroids. It is expected that the frequency of hysterectomies for non-malignant indications will continue to fall given the development of alternative treatment options.

<span class="mw-page-title-main">Misoprostol</span> Medication to induce abortion and treat ulcers

Misoprostol is a synthetic prostaglandin medication used to prevent and treat stomach and duodenal ulcers, induce labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus. It is taken by mouth when used to prevent gastric ulcers in people taking nonsteroidal anti-inflammatory drugs (NSAID). For abortions it is used by itself or in conjunction with mifepristone or methotrexate. By itself, effectiveness for abortion is between 66% and 90%. For labor induction or abortion, it is taken by mouth, dissolved in the mouth, or placed in the vagina. For postpartum bleeding it may also be used rectally.

Heavy menstrual bleeding (HMB), previously known as menorrhagia or hematomunia, is a menstrual period with excessively heavy flow. It is a type of abnormal uterine bleeding (AUB).

<span class="mw-page-title-main">Placenta praevia</span> Medical condition

Placenta praevia is when the placenta attaches inside the uterus but in a position near or over the cervical opening. Symptoms include vaginal bleeding in the second half of pregnancy. The bleeding is bright red and tends not to be associated with pain. Complications may include placenta accreta, dangerously low blood pressure, or bleeding after delivery. Complications for the baby may include fetal growth restriction.

<span class="mw-page-title-main">Vaginal bleeding</span> Medical condition

Vaginal bleeding is any expulsion of blood from the vagina. This bleeding may originate from the uterus, vaginal wall, or cervix. Generally, it is either part of a normal menstrual cycle or is caused by hormonal or other problems of the reproductive system, such as abnormal uterine bleeding.

Antepartum bleeding, also known as antepartum haemorrhage (APH) or prepartum hemorrhage, is genital bleeding during pregnancy after the 28th week of pregnancy up to delivery.

<span class="mw-page-title-main">Uterine artery embolization</span>

Uterine artery embolization is a procedure in which an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the uterine body. The procedure is primarily done for the treatment of uterine fibroids and adenomyosis. Since uterine fibroids are the most common indication, it is also often referred to as uterine fibroid embolization. Compared to surgical treatment for fibroids such as a hysterectomy, in which a woman's uterus is removed, uterine artery embolization may be beneficial in women who wish to retain their uterus. Other reasons for uterine artery embolization are postpartum hemorrhage and uterine arteriovenous malformations.

<span class="mw-page-title-main">International Federation of Gynaecology and Obstetrics</span> Professional medical organization

The International Federation of Gynaecology and Obstetrics, usually just FIGO ("fee'go") as the acronym of its French name Fédération Internationale de Gynécologie et d'Obstétrique, is a worldwide non-governmental organisation representing obstetricians and gynaecologists in over one hundred territories. It was founded on 26 July 1954 in Geneva, Switzerland, to "promote the well-being of women and to raise the standard of practice in obstetrics and gynaecology". Membership is currently composed of 132 professional societies of obstetricians and gynaecologists worldwide.

<span class="mw-page-title-main">Placenta accreta spectrum</span> Medical condition

Placenta accreta occurs when all or part of the placenta attaches abnormally to the myometrium. Three grades of abnormal placental attachment are defined according to the depth of attachment and invasion into the muscular layers of the uterus:

  1. Accreta – chorionic villi attached to the myometrium, rather than being restricted within the decidua basalis.
  2. Increta – chorionic villi invaded into the myometrium.
  3. Percreta – chorionic villi invaded through the perimetrium.
<span class="mw-page-title-main">Balloon tamponade</span>

Balloon tamponade usually refers to the use of balloons inserted into the esophagus, stomach or uterus, and inflated to alleviate or stop refractory bleeding.

<span class="mw-page-title-main">Uterine atony</span> Loss of tone in the uterine musculature

Uterine atony is the failure of the uterus to contract adequately following delivery. Contraction of the uterine muscles during labor compresses the blood vessels and slows flow, which helps prevent hemorrhage and facilitates coagulation. Therefore, a lack of uterine muscle contraction can lead to an acute hemorrhage, as the vasculature is not being sufficiently compressed. Uterine atony is the most common cause of postpartum hemorrhage, which is an emergency and potential cause of fatality. Across the globe, postpartum hemorrhage is among the top five causes of maternal death. Recognition of the warning signs of uterine atony in the setting of extensive postpartum bleeding should initiate interventions aimed at regaining stable uterine contraction.

<span class="mw-page-title-main">Postpartum bleeding</span> Loss of blood following childbirth

Postpartum bleeding or postpartum hemorrhage (PPH) is often defined as the loss of more than 500 ml or 1,000 ml of blood following childbirth. Some have added the requirement that there also be signs or symptoms of low blood volume for the condition to exist. Signs and symptoms may initially include: an increased heart rate, feeling faint upon standing, and an increased breathing rate. As more blood is lost, the patient may feel cold, blood pressure may drop, and they may become restless or unconscious. The condition can occur up to six weeks following delivery.

<span class="mw-page-title-main">Non-pneumatic anti-shock garment</span> Device used to treat hypovolemic shock

The non-pneumatic anti-shock garment (NASG) is a low-technology first-aid device used to treat hypovolemic shock. Its efficacy for reducing maternal deaths due to obstetrical hemorrhage is being researched. Obstetrical hemorrhage is heavy bleeding of a woman during or shortly after a pregnancy. Current estimates suggest over 300,000 women die from obstetrical hemorrhage every year with 99% of cases occurring in developing countries; many of these deaths are preventable. Many women in resource-poor settings deliver far from health-care facilities. Once hemorrhage has been identified, many women die before reaching or receiving adequate treatment. The NASG can be used to keep women alive until they can get the treatment they need.

A uterotonic, also known as an oxytocic or ecbolic, is a type of medication used to induce contraction or greater tonicity of the uterus. Uterotonics are used both to induce labor and to reduce postpartum hemorrhage.

<span class="mw-page-title-main">B-Lynch suture</span>

The B-Lynch suture or B-Lynch procedure is a form of compression suture used in obstetrics. It is used to mechanically compress an atonic uterus in the face of severe postpartum hemorrhage. It was developed by Christopher B-Lynch, a consultant obstetrician and gynaecological surgeon based at Milton Keynes General Hospital, Milton Keynes, Buckinghamshire, England. B-Lynch was born in 1947 in Sierra Leone with the birth name of Christopher Balogun-Lynch.

The Bakri Balloon is a medical device invented and designed by Dr. Younes Bakri in 1999.

<span class="mw-page-title-main">FIGO classification of uterine bleeding</span>

The International Federation of Gynecology and Obstetrics is an international organization that links about 125 international professional societies of Obstetricians and Gynecologists. In 2011 FIGO recognized two systems designed to aid research, education, and clinical care of women with abnormal uterine bleeding (AUB) in the reproductive years. This page is a summary of the systems and their use in contemporary gynecology.

Sayeba Akhter is a Bangladeshi physician who has dedicated her career to eliminating obstetric fistula. She is an executive member of the International Society of Obstetric Fistula Surgeons and has previously served as the president of the Obstetrics and Gynaecology Society of Bangladesh. She leads two charities, in Dhaka and Gaibandha, which focus on the education of underprivileged girls.

Metropathia haemorrhagica, also known as metropathia haemorrhagica cystica, is a menstrual disorder which is defined as a specialized type of anovulatory dysfunctional uterine bleeding associated with endometrial hyperplasia and intermenstrual bleeding. The condition was defined by 1930. It has been agreed that the term "metropathia haemorrhagica" should be discarded along with many other older terms for menstrual disorders.

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. S2CID   20479682.
  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. 1 2 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 (Press release). Retrieved 2020-04-11.
  12. 1 2 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. 1 2 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. 1 2 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. S2CID   23406726.
  15. 1 2 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. 1 2 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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