title: Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial.
abstract: BACKGROUND
  Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births.
  
  
  RESULTS
  This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls.
  
  
  CONCLUSIONS
  Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01108289 Please see later in the article for the Editors' Summary.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Cynthia K
authors.initials: CK
authors.lastname: Stanton
authors.forename: Samuel
authors.initials: S
authors.lastname: Newton
authors.forename: Luke C
authors.initials: LC
authors.lastname: Mullany
authors.forename: Patience
authors.initials: P
authors.lastname: Cofie
authors.forename: Charlotte
authors.initials: C
authors.lastname: Tawiah Agyemang
authors.forename: Edward
authors.initials: E
authors.lastname: Adiibokah
authors.forename: Seeba
authors.initials: S
authors.lastname: Amenga-Etego
authors.forename: Niamh
authors.initials: N
authors.lastname: Darcy
authors.forename: Sadaf
authors.initials: S
authors.lastname: Khan
authors.forename: Deborah
authors.initials: D
authors.lastname: Armbruster
authors.forename: John
authors.initials: J
authors.lastname: Gyapong
authors.forename: Seth
authors.initials: S
authors.lastname: Owusu-Agyei
mesh_terms: D005260:Female; D005869:Ghana; D006801:Humans; D010121:Oxytocin / Q000008:administration & dosage / Q000009:adverse effects / Q000633:toxicity*; D006473:Postpartum Hemorrhage / Q000188:drug therapy*; D011247:Pregnancy
chemical_list: D010121:Oxytocin