Objective To evaluate the effectiveness and safety of an ultra-lowcost uterine balloon tamponade package (ESM-UBTTM) for facility-based management of uncontrolled postpartum haemorrhage (PPH) in Kenya, Sierra Leone, Senegal, and Nepal.Design Prospective multi-centre case series.Setting Facilities in resource-scarce areas of Kenya, Sierra Leone, Nepal, and Senegal.Population Women with uncontrolled postpartum haemorrhage in 307 facilities across the four countries.Methods A standardised ESM-UBT package was implemented in 307 facilities over 29 months (1 September 2012 to 1 February 2015. Data were collected via a multi-pronged approach including data card completion, chart reviews, and provider interviews. Beginning in August 2014, women who had previously undergone UBT placement were sought and queried regarding potential complications associated with UBT use.Main outcome measures All-cause survival, survival from PPH, and post-UBT use complications (surgery, hospitalisation, antibiotics for pelvic infection) associated with UBT use.Results 201 UBTs were placed for uncontrolled vaginal haemorrhage refractory to all other interventions. In all, 38% (71/ 188) of women were either unconscious or confused at the time of UBT insertion. All-cause survival was 95% (190/201). However, 98% (160/163) of women survived uncontrolled PPH if delivery occurred at an ESM-UBT online facility. One (1/151) potential UBT-associated complication (postpartum endometritis) was identified and two improvised UBTs were placed in women with a ruptured uterus.Conclusions These pilot data suggest that the ESM-UBT package is a clinically promising and safe method to arrest uncontrolled postpartum haemorrhage and save women's lives. The UBT was successfully placed by all levels of facility-based providers. Future studies are needed to further evaluate the effectiveness of ESM-UBT in low-resource settings.Keywords Maternal mortality, postpartum haemorrhage, uterine balloon tamponade. Please cite this paper as: Burke TF, Ahn R, Nelson BD, Hines R, Kamara J, Oguttu M, Dulo L, Achieng E, Achieng B, Natarajan A, Maua J, Kargbo SAS, Altawil Z, Tester K, de Redon E, Niang M, Abdalla K, Eckardt MJ. A postpartum haemorrhage package with condom uterine balloon tamponade: a prospective multi-centre case series in Kenya, Sierra Leone, Senegal, and Nepal. BJOG 2016;123:1532-1540

This study provides promising initial evidence that the ESM-Ketamine package can support emergency and life-improving surgeries in resource-limited settings when no anesthetist is available.

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.