Person:

Burke, Thomas

Objective: To understand healthcare providers’ experiences with improvised uterine balloon tamponade (UBT) for the management of uncontrolled postpartum hemorrhage (PPH). Methods: In a qualitative descriptive study, in-depth semi-structured interviews were conducted between November 2014 and June 2015 among Kenyan healthcare providers who had previous experience with improvising a UBT device. Interviews were conducted, audio-recorded, and transcribed. Results: Overall, 29 healthcare providers (14 nurse-midwifes, 7 medical officers, 7 obstetricians, and 1 clinical officer) were interviewed. Providers perceived improvised UBT as valuable for managing uncontrolled PPH. Reported benefits included effectiveness in arresting hemorrhage and averting hysterectomy, and ease of use by providers of all levels of training. Providers used various materials to construct an improvised UBT. Challenges to improvising UBT—e.g. searching for materials during an emergency, procuring male condoms, and inserting fluid via a small syringe—were reported to lead to delays in care. Providers described their introduction to improvised UBT through both formal and informal sources. There was universal enthusiasm for widespread standardized training. Conclusion: Improvised UBT seems to be a valuable second-line treatment for uncontrolled PPH that can be used by providers of all levels. UBT might be optimized by integrating a standard package across the health system.

Background: Postpartum 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. Methods: Data 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. Results: Of 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. Conclusion: The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

Background: Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide. This study sought to quantify the potential health impact (morbidity and mortality reductions) that a low-cost uterine balloon tamponade (UBT) could have on women suffering from uncontrolled PPH due to uterine atony in sub-Saharan Africa. Methods: The Maternal and Neonatal Directed Assessment of Technology (MANDATE) model was used to estimate maternal deaths, surgeries averted, and cases of severe anemia prevented through UBT use among women with PPH who receive a uterotonic drug but fail this therapy in a health facility. Estimates were generated for the year 2018. The main outcome measures were lives saved, surgeries averted, and severe anemia prevented. Results: The base case model estimated that widespread use of a low-cost UBT in clinics and hospitals could save 6547 lives (an 11% reduction in maternal deaths), avert 10,823 surgeries, and prevent 634 severe anemia cases in sub-Saharan Africa annually. Conclusions: A low-cost UBT has a strong potential to save lives and reduce morbidity. It can also potentially reduce costly downstream interventions for women who give birth in a health care facility. This technology may be especially useful for meeting global targets for reducing maternal mortality as identified in Sustainable Development Goal 3.