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

UBT has been readily accepted by providers at all levels of training and is being incorporated into the existing PPH management algorithm in Kenya.

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in Kenya. The aim of this study was to measure quality and timeliness of care for PPH in a sample of deliveries in referral hospitals in Kenya. We conducted direct observations of 907 vaginal deliveries in three Kenyan hospitals from October 2018 through February 2019, observing the care women received from admission for labor and delivery through hospital discharge. We identified cases of “suspected PPH”, defined as cases in which providers indicated suspicion of and/or took an action to manage abnormal bleeding. We measured adherence to World Health Organization and Kenyan guidelines for PPH risk assessment, prevention, identification, and management and the timeliness of care in each domain. The rate of suspected PPH among the observed vaginal deliveries was 9% (95% Confidence Interval: 7% - 11%). Health care providers followed all guidelines for PPH risk assessment in 7% (5% - 10%) of observed deliveries and all guidelines for PPH prevention in 4% (3% - 6%) of observed deliveries. Lowest adherence was observed for taking vital signs and for timely administration of a prophylactic uterotonic. Providers did not follow guidelines for postpartum monitoring in any of the observed deliveries. When suspected PPH occurred, providers performed all recommended actions in 23% (6% - 40%) of cases. Many of the critical actions for suspected PPH were performed in a timely manner, but, in some cases, substantial delays were observed. In conclusion, we found significant gaps in the quality of risk assessment, prevention, identification, and management of PPH after vaginal deliveries in referral hospitals in Kenya. Efforts to reduce maternal morbidity and mortality from PPH should emphasize improvements in the quality of care, with a particular focus on postpartum monitoring and timely emergency response.