Umbilical vein oxytocin for the treatment of retained placenta (Release Study): a double-blind, randomised controlled trial.
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.
Weeks
Andrew D
AD
School of Reproductive and Developmental Medicine, University of Liverpool, Liverpool, UK. aweeks@liv.ac.uk
Alia
Godfrey
G
Vernon
Gillian
G
Namayanja
Annette
A
Gosakan
Radhika
R
Majeed
Tayyaba
T
Hart
Anna
A
Jafri
Hussain
H
Nardin
Juan
J
Carroli
Guillermo
G
Fairlie
Fiona
F
Raashid
Yasmin
Y
Mirembe
Florence
F
Alfirevic
Zarko
Z
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
D006454:Hemoglobins; D010120:Oxytocics; D010121:Oxytocin