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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., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objective: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH)., Methods: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting., Results: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements., Conclusion: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices., (© 2019 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

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.

Objective: To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device., Methods: In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement., Results: Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25)., Conclusion: The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony., (© 2017 International Federation of Gynecology and Obstetrics.)