A narrative review comparing clinical effectiveness of commonly used uterine balloon tamponade devices for postpartum haemorrhage management in India
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20222509Keywords:
Uterine Balloon Tamponade, Clinical effectiveness, Bakri balloon UBT, Condom-UBT, ESM-UBT, Postpartum haemorrhageAbstract
Background: World Health Organisation recommends using Uterine Balloon Tamponade (UBT) for refractory atonic postpartum haemorrhage (PPH) management provided treatment protocols and surgical recourse is possible.
Methods: This review collated literature from three electronic databases between January 2010 to December 2019 to compare clinical effectiveness, safety and use related parameters for condom-UBT, Bakri balloon and Every Second Matters (ESM) UBT devices used in India.
Results: Thirty-three eligible studies reported effectiveness in managing all PPH causes ranging from 84.2% to 98.3% for condom-UBT and from 65.3% to 94.8% for Bakri-UBT. Three ESM-UBT studies reported PPH survival rates of 94% to 97.4%. Mean UBT effectiveness in controlling atonic PPH was 92.3% for condom-UBT, 84.3% for Bakri-UBT and 97.3% for ESM-UBT. Condom-UBT and Bakri-UBT were comparable across parameters whereas limited ESM-UBT evidence reported success in preventing maternal deaths.
Conclusions: For limitations and heterogeneity in methodology and outcome parameters with existing evidence, a robust comparative RCT between UBT devices in India is recommended.
References
Say L, Chou D, Gemmill A, et al. Global causes of maternal death: A WHO systematic analysis. Lancet Glob Health. 2014;2(6):323-333. doi:10.1016/S2214-109X(14)70227-X
Vogel JP, Oladapo OT, Dowswell T, Gülmezoglu AM. Updated WHO recommendation on intravenous tranexamic acid for the treatment of post-partum haemorrhage. Lancet Glob Health. 2018;6(1):e18-e19. doi:10.1016/S2214-109X(17)30428-X
Likis FE, Nila Sathe FA, Alicia Morgans MK, et al. Management of Postpartum Hemorrhage Comparative Effectiveness Review Management of Postpartum Hemorrhage. Published online 2015.
Dept. of Reproductive Health and Research W. WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage.; 2012.
WHO recommendation on Uterine balloon tamponade for the treatment of postpartum haemorrhage. WHO Recomm Uterine Balloon Tamponade Treat Postpartum Haemorrhage. Published online 2021.
Georgiou. Balloon tamponade review. J Obstet Gynaecol - Wiley Online Libr. Published online 2009.
Tunçalp Ö, Souza JP, Gülmezoglu M. New WHO recommendations on prevention and treatment of postpartum hemorrhage. Int J Gynecol Obstet. 2013;123(3):254-256. doi:10.1016/j.ijgo.2013.06.024
Division MH, Welfare F. Guidance Note on Prevention and Management of Postpartum Haemorrhage.
Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, et al. Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis. Am J Obstet Gynecol. Published online 2020. doi:10.1016/j.ajog.2019.11.1287
Division MH, Welfare F. TRAINEES ’ HANDBOOK for TRAINING of Medical Officers in Pregnancy Care and Management of Common Obstetric Complications. 2009;(August).
Darwish AM, Abdallah MM, Shaaban OM, Ali MK, Khalaf M, Sabra AMA. Bakri balloon versus condom-loaded Foley’s catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018;31(6):747-753. doi:10.1080/14767058.2017.1297407
Dumont A, Bodin C, Hounkpatin B, et al. Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: A randomised controlled trial in Benin and Mali. BMJ Open. 2017;7(9):1-9. doi:10.1136/bmjopen-2017-016590
Anger HA, Dabash R, Durocher J, et al. The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomised trial. BJOG Int J Obstet Gynaecol. 2019;126(13):1612-1621. doi:10.1111/1471-0528.15903
Developing Countries 2020. Accessed March 31, 2020. https://worldpopulationreview.com/countries/developing-countries/
Burke TF, Ahn R, Nelson BD, et al. A postpartum haemorrhage package with condom uterine balloon tamponade: a prospective multi-centre case series in Kenya, Sierra Leone, Senegal, and Nepal. BJOG Int J Obstet Gynaecol. 2016;123(9):1532-1540. doi:10.1111/1471-0528.13550
Ramanathan A, Eckardt MJ, Nelson BD, et al. Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone. BMC Pregnancy Childbirth. 2018;18(1):1-7. doi:10.1186/s12884-018-1808-z
Mathur M, Ng QJ, Tagore S. Use of Bakri balloon tamponade (BBT) for conservative management of postpartum haemorrhage: a tertiary referral centre case series. J Obstet Gynaecol. 2018;38(1):66-70. doi:10.1080/01443615.2017.1328671
Tindell K, Garfinkel R, Abu-Haydar E, et al. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: A systematic review. BJOG Int J Obstet Gynaecol. 2013;120(1):5-14. doi:10.1111/j.1471-0528.2012.03454.x
Rathore AM, Gupta S, Manaktala U, Gupta S, Dubey C, Khan M. Uterine tamponade using condom catheter balloon in the management of non-traumatic postpartum hemorrhage. J Obstet Gynaecol Res. 2012;38(9):1162-1167. doi:10.1111/j.1447-0756.2011.01843.x
Guo Y, Hua R, Bian S, et al. Intrauterine Bakri Balloon and Vaginal Tamponade Combined with Abdominal Compression for the Management of Postpartum Hemorrhage. J Obstet Gynaecol Can. 2018;40(5):561-565. doi:10.1016/j.jogc.2017.08.035
Grange J, Chatellier M, Chevé MT, et al. Predictors of failed intrauterine balloon tamponade for persistent postpartum hemorrhage after vaginal delivery. PLoS ONE. 2018;13(10):1-11. doi:10.1371/journal.pone.0206663
Çetin BA, Aydogan Mathyk B, Atis Aydin A, et al. Comparing success rates of the Hayman compression suture and the Bakri balloon tamponade. J Matern Fetal Neonatal Med. 2019;32(18):3034-3038. doi:10.1080/14767058.2018.1455184
Yadav S, Malhotra A. A prospective randomized comparative study of Misoprostol and balloon tamponade using condom catheter to prevent postpartum hemorrhage at M. Y. H., Indore, India in vaginal delivered patients. Int J Reprod Contracept Obstet Gynecol. 2019;8(2):591. doi:10.18203/2320-1770.ijrcog20190290
Darwish AM, Abdallah MM, Shaaban OM, Ali MK, Khalaf M, Sabra AMA. Bakri balloon versus condom-loaded Foley’s catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018;31(6):747-753. doi:10.1080/14767058.2017.1297407
Mishra N, Gulabani K, Agrawal S, Shrivastava C. Efficacy and Feasibility of Chhattisgarh Balloon and Conventional Condom Balloon Tamponade: A 2-Year Prospective Study. J Obstet Gynecol India. 2019;69:133-141. doi:10.1007/s13224-018-1185-6
Alkiş I, Karaman E, Han A, Ark HC, Büyükkaya B. The fertility sparing management of postpartum hemorrhage: A series of 47 cases of Bakri balloon tamponade. Taiwan J Obstet Gynecol. 2015;54(3):232-235. doi:10.1016/j.tjog.2014.03.009
Gauchotte E, De La Torre M, Perdriolle-Galet E, Lamy C, Gauchotte G, Morel O. Impact of uterine balloon tamponade on the use of invasive procedures in severe postpartum hemorrhage. Acta Obstet Gynecol Scand. 2017;96(7):877-882. doi:10.1111/aogs.13130
Kadioglu BG, Tanriverdi EC, Aksoy AN. Balloon Tamponade in the Management of Postpartum Hemorrhage: Three Years of Experience in a Single Center. Open J Obstet Gynecol. 2016;06(12):698-704. doi:10.4236/ojog.2016.612087
Burke TF, Danso-Bamfo S, Guha M, Oguttu M, Tarimo V, Nelson BD. Shock progression and survival after use of a condom uterine balloon tamponade package in women with uncontrolled postpartum hemorrhage. Int J Gynecol Obstet. 2017;139(1):34-38. doi:10.1002/ijgo.12251
Santhanam R, Viswanathan RM, V. P. Condom tamponade in the management of atonic postpartum hemorrhage. Int J Reprod Contracept Obstet Gynecol. 2018;7(6):2276. doi:10.18203/2320-1770.ijrcog20182335
Lohano R, Haq G, Kazi S, Sheikh S. Intrauterine balloon tamponade for the control of postpartum haemorrhage. J Pak Med Assoc. 2016;66(1):22-26.
Vintejoux E, Ulrich D, Mousty E, et al. Success factors for BakriTM balloon usage secondary to uterine atony: A retrospective, multicentre study. Aust N Z J Obstet Gynaecol. 2015;55(6):572-577. doi:10.1111/ajo.12376
Wang D, Xu S, Qiu X, et al. Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: A large prospective, observational multicenter clinical study in South China. J Perinat Med. 2018;46(6):649-656. doi:10.1515/jpm-2017-0249
Hasabe R, Gupta K, Rathode P. Use of Condom Tamponade to Manage Massive Obstetric Hemorrhage at a Tertiary Center in Rajasthan. J Obstet Gynecol India. 2016;66(October):88-93. doi:10.1007/s13224-015-0790-x
Kandeel M, Sanad Z, Ellakwa H, El Halaby A, Rezk M, Saif I. Management of postpartum hemorrhage with intrauterine balloon tamponade using a condom catheter in an Egyptian setting. Int J Gynecol Obstet. 2016;135(3):272-275. doi:10.1016/j.ijgo.2016.06.018
Son M, Einerson BD, Schneider P, Fields IC, Grobman WA, Miller ES. Is There an Association between Indication for Intrauterine Balloon Tamponade and Balloon Failure? Am J Perinatol. 2017;34(2):164-168. doi:10.1055/s-0036-1585084
Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG Int J Obstet Gynaecol. 2017;124(8):1255-1262. doi:10.1111/1471-0528.14382
Martin E, Legendre G, Bouet PE, Cheve MT, Multon O, Sentilhes L. Maternal outcomes after uterine balloon tamponade for postpartum hemorrhage. Acta Obstet Gynecol Scand. 2015;94(4):399-404. doi:10.1111/aogs.12591
Kaya B, Tuten A, Daglar K, et al. Balloon tamponade for the management of postpartum uterine hemorrhage. J Perinat Med. 2014;42(6):745-753. doi:10.1515/jpm-2013-0336
Ogoyama M, Takahashi H, Usui R, et al. Hemostatic effect of intrauterine balloon for postpartum hemorrhage with special reference to concomitant use of “holding the cervix” procedure (Matsubara). Eur J Obstet Gynecol Reprod Biol. 2017;210:281-285. doi:10.1016/j.ejogrb.2017.01.012
Aderoba AK, Olagbuji BN, Akintan AL, Oyeneyin OL, Owa OO, Osaikhuwuomwan JA. Condom-catheter tamponade for the treatment of postpartum haemorrhage and factors associated with success: a prospective observational study. BJOG Int J Obstet Gynaecol. 2017;124(11):1764-1771. doi:10.1111/1471-0528.14361
Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012;207(4):281.e1-281.e7. doi:10.1016/j.ajog.2012.08.028
Kong CW, To WW. Prognostic factors for the use of intrauterine balloon tamponade in the management of severe postpartum hemorrhage. Int J Gynecol Obstet. 2018;142(1):48-53. doi:10.1002/ijgo.12498
Olsen R, Reisner DP, Benedetti TJ, Dunsmoor-Su RF. Bakri balloon effectiveness for postpartum hemorrhage: A “real world experience.” J Matern Fetal Neonatal Med. 2013;26(17):1720-1723. doi:10.3109/14767058.2013.796354
Greenberg JA, Sugrue R. Questionable conclusions about uterine balloon tamponade. Am J Obstet Gynecol. 2020;223(6):946-947. doi:10.1016/j.ajog.2020.07.04