title: A postpartum haemorrhage package with condom uterine balloon tamponade: a prospective multi-centre case series in Kenya, Sierra Leone, Senegal, and Nepal.
abstract: OBJECTIVE
  To evaluate the effectiveness and safety of an ultra-low-cost uterine balloon tamponade package (ESM-UBT™) for facility-based management of uncontrolled postpartum haemorrhage (PPH) in Kenya, Sierra Leone, Senegal, and Nepal.
  
  
  METHODS
  Prospective multi-centre case series.
  
  
  METHODS
  Facilities in resource-scarce areas of Kenya, Sierra Leone, Nepal, and Senegal.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Evidence for ESM-UBT as a clinically promising and safe method to arrest uncontrolled PPH and save women's lives.
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: T F
authors.initials: TF
authors.lastname: Burke
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Ahn
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: B D
authors.initials: BD
authors.lastname: Nelson
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Hines
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Kamara
authors.affiliation: Kisumu Medical and Education Trust, Kisumu, Kenya.
authors.forename: M
authors.initials: M
authors.lastname: Oguttu
authors.affiliation: Kisumu Medical and Education Trust, Kisumu, Kenya.
authors.forename: L
authors.initials: L
authors.lastname: Dulo
authors.affiliation: Kisumu Medical and Education Trust, Kisumu, Kenya.
authors.forename: E
authors.initials: E
authors.lastname: Achieng
authors.affiliation: Kisumu Medical and Education Trust, Kisumu, Kenya.
authors.forename: B
authors.initials: B
authors.lastname: Achieng
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Natarajan
authors.affiliation: Division of Reproductive and Maternal Health, Ministry of Health, Nairobi, Kenya.
authors.forename: J
authors.initials: J
authors.lastname: Maua
authors.affiliation: Division of Reproductive Health, Ministry of Health and Sanitation, Freetown, Sierra Leone.
authors.forename: Sas
authors.initials: S
authors.lastname: Kargbo
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Altawil
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: K
authors.initials: K
authors.lastname: Tester
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: E
authors.initials: E
authors.lastname: de Redon
authors.affiliation: Centre de Formation et de Recherche en Santé de la Reproduction, Dakar, Senegal.
authors.forename: M
authors.initials: M
authors.lastname: Niang
authors.affiliation: UNICEF, Nairobi, Kenya.
authors.forename: K
authors.initials: K
authors.lastname: Abdalla
authors.affiliation: Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.|Department of Obstetrics and Gynecology, Boston Medical Center, Boston, MA, USA.
authors.forename: M J
authors.initials: MJ
authors.lastname: Eckardt
mesh_terms: D000293:Adolescent; D000328:Adult; D001942:Breast Feeding; D002584:Cervix Uteri / Q000293:injuries / Q000601:surgery; D057189:Checklist; D017280:Condoms; D005260:Female; D006295:Health Resources; D006801:Humans; D007630:Kenya; D022125:Lacerations / Q000601:surgery; D008405:Massage; D008875:Middle Aged; D016595:Misoprostol / Q000627:therapeutic use; D009390:Nepal; D010120:Oxytocics / Q000627:therapeutic use*; D010121:Oxytocin / Q000627:therapeutic use; D010502:Perineum / Q000293:injuries / Q000601:surgery; D010865:Pilot Projects; D006473:Postpartum Hemorrhage / Q000628:therapy*; D011446:Prospective Studies; D012675:Senegal; D012807:Sierra Leone; D015996:Survival Rate; D062885:Urinary Catheters; D058738:Uterine Balloon Tamponade / Q000295:instrumentation* / Q000379:methods; D055815:Young Adult
chemical_list: D010120:Oxytocics; D016595:Misoprostol; D010121:Oxytocin
keywords: Maternal mortality; postpartum haemorrhage; uterine balloon tamponade