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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. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of introducing a uterine balloon tamponade (ESM‐UBT) device for managing severe postpartum hemorrhage (PPH), mainly due to uterine atony, in health facilities in India on the rates of PPH‐related maternal death and invasive procedures for PPH control. Methods: We used a quasi‐experimental, difference‐in‐difference (DID) design to compare changes in the rates of a composite outcome (PPH‐related maternal death and/or artery ligation, uterine compression sutures, or hysterectomy) among women delivering in nine intervention facilities compared with those delivering in two control facilities, before and after the introduction of ESM‐UBT. Results: The study sample included 214 123 deliveries (n = 78 509 before ESM‐UBT introduction; n = 47 211 during ESM‐UBT introduction; and n = 88 403 after ESM‐UBT introduction). After introduction of ESM‐UBT, there was a significant decline in the rate of the primary composite outcome in intervention facilities (21.0–11.4 per 10 000 deliveries; difference −9.6, 95% confidence interval −14.0 to −5.4). Change in the rate of the primary composite outcome was not significant in control facilities (11.7–17.2 per 10 000 deliveries; difference 5.4, 95% confidence interval −3.9 to 14.9). DID analyses showed there was a significant reduction in the rate of the primary composite outcome in intervention facilities relative to control facilities (adjusted DID estimate −15.0 per 10 000 points, 95% confidence interval −23.3 to −6.8; P = 0.005). Conclusion: Introduction of the ESM‐UBT in health facilities in India was associated with a significant reduction in PPH‐related maternal death and/or invasive procedures for PPH control. Introduction of a uterine balloon tamponade device for managing severe postpartum hemorrhage in health facilities in India significantly reduced maternal death and/or invasive procedures. [ABSTRACT FROM AUTHOR]