Data from: 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. FINDINGS: 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. INTERPRETATION: Umbilical oxytocin has no
clinically significant effect on the need for manual removal for women
with retained placenta. FUNDING: WHO, WellBeing of Women, Pakistan Higher
Education Commission.