title: Umbilical vein oxytocin for the treatment of retained placenta (Release Study): a double-blind, randomised controlled trial.
abstract: BACKGROUND
  Retained placenta is associated with post-partum haemorrhage. Meta-analysis has suggested that umbilical injection of oxytocin could increase placental expulsion without the need for a surgeon or anaesthetic. We assessed the effect of high-dose umbilical vein oxytocin as a treatment for retained placenta.
  
  
  METHODS
  In this double-blind, placebo-controlled trial, haemodynamically stable women with a retained placenta for more than 30 min were recruited from 13 sites in the UK, Uganda, and Pakistan. 577 women were randomly assigned by a computer-generated randomisation list stratified by centre to 30 mL saline containing either 50 IU oxytocin (n=292) or 5 mL water (n=285), which was injected into the placenta through an umbilical vein catheter. All trial participants, study workers, and data handlers were masked to individual allocations. The primary outcome was the need for manual removal of the placenta. Analysis was by intention to treat. This study is registered, number ISRCTN 13204258.
  
  
  RESULTS
  The primary outcome was recorded for all participants. We detected no difference between the groups in the need for manual removal of placenta (oxytocin 179/292 [61.3%] vs placebo 177/285 [62.1%]; relative risk 0.98, 95% CI 0.87-1.12; p=0.84). The need for manual removal was higher in the UK (overall 250/361 [69%]) than in Uganda (90/190 [47%]) or Pakistan (16/26 [62%]). Adverse events did not differ between the two groups.
  
  
  CONCLUSIONS
  Umbilical oxytocin has no clinically significant effect on the need for manual removal for women with retained placenta.
  
  
  BACKGROUND
  WHO, WellBeing of Women, Pakistan Higher Education Commission.
authors.affiliation: School of Reproductive and Developmental Medicine, University of Liverpool, Liverpool, UK. aweeks@liv.ac.uk
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Weeks
authors.forename: Godfrey
authors.initials: G
authors.lastname: Alia
authors.forename: Gillian
authors.initials: G
authors.lastname: Vernon
authors.forename: Annette
authors.initials: A
authors.lastname: Namayanja
authors.forename: Radhika
authors.initials: R
authors.lastname: Gosakan
authors.forename: Tayyaba
authors.initials: T
authors.lastname: Majeed
authors.forename: Anna
authors.initials: A
authors.lastname: Hart
authors.forename: Hussain
authors.initials: H
authors.lastname: Jafri
authors.forename: Juan
authors.initials: J
authors.lastname: Nardin
authors.forename: Guillermo
authors.initials: G
authors.lastname: Carroli
authors.forename: Fiona
authors.initials: F
authors.lastname: Fairlie
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Raashid
authors.forename: Florence
authors.initials: F
authors.lastname: Mirembe
authors.forename: Zarko
authors.initials: Z
authors.lastname: Alfirevic
mesh_terms: D000328:Adult; D000768:Anesthesia, General / Q000706:statistics & numerical data; D001794:Blood Pressure; D001803:Blood Transfusion / Q000706:statistics & numerical data; D004311:Double-Blind Method; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007275:Injections, Intravenous; D010120:Oxytocics / Q000627:therapeutic use*; D010121:Oxytocin / Q000627:therapeutic use*; D010154:Pakistan / Q000453:epidemiology; D018457:Placenta, Retained / Q000628:therapy*; D006473:Postpartum Hemorrhage / Q000453:epidemiology; D011247:Pregnancy; D014454:Uganda / Q000453:epidemiology; D014471:Umbilical Veins; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D006454:Hemoglobins; D010120:Oxytocics; D010121:Oxytocin