Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone

Abstract

BackgroundPostpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone.MethodsData were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis.ResultsOf the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely.ConclusionThe ESM-UBT device appears safe for use in women with uncontrolled PPH.Trial registrationTrial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

Mechanical Properties of the Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) Device: In Vitro Tests

“…Reliance on skilled birth attendants to improvise UBT devices is fraught with suboptimal equipment, delays in device assembly, and poor uptake by providers across health systems. 21 27 28 29 The ESM-UBT device was designed to overcome each of the challenges posed by commercial and improvised UBT devices. This study demonstrates that ESM-UBT devices maintain their pressures and integrity over the course of a series of experiments designed to stress and evaluate the ESM-UBT system.…”

“…These devices require assembly; however, their low cost of materials makes them attractive options for resource-poor settings. 19 20 21 22 23 Reported rates (75–94%) of hemorrhage arrest among women that received commercial or condom-catheter UBTs have been encouraging. 7 13 24 25…”

“…ESM-UBT devices are being used in over 20 countries worldwide. 21 27 28 29 To-date, over 1,000 ESM-UBT devices have been placed in women with uncontrolled PPH in Kenya alone with survival rates of 95% overall. If placed prior to advanced shock, survival rates approach 100%.…”

Obstetric hemorrhage in resource‐limited locations: A quality improvement project after adoption of abdominopelvic compression devices

“…Intrauterine balloons are used when bleeding is due to atony. In a resource‐limited setting, a maternal survival rate of 94% was reported with a condom catheter device 20 …”

Impact of condom balloon tamponade on the rate of obstetric hysterectomy: a ten-year study

“…[19][20][21][22][23] Use of C-UBT has extended for uncontrolled PPH in hemodynamically unstable patients also. [24][25][26][27][28][29] The only RCT comparing Bakri balloon® with C-UBT also reported no significant difference between the two in terms of success. 30 The advantages of C-UBT are many like being least invasive, cheapest, most rapid, safe, highly effective and need minimum training as well as clinical skill.…”