Umbilical Vein Oxytocin for the Treatment of Retained Placenta (Release Study): A Double-Blind, Randomized Controlled Trial

Women who have a retained placenta are at high risk of postpartum hemorrhage without prompt treatment. The facilities and skilled personnel needed to perform manual removal of the placenta, the current treatment, are often unavailable to women in rural resource-poor settings, and the case fatality rate is nearly 10% in such settings. Some investigators have suggested that administration of oxytocin via the umbilical vein and placenta is a low-cost low technology method that could increase placental expulsion. A number of small studies reported that umbilical injection of oxytocin was an effective intervention, while a meta-analysis (Cochrane review) suggested that this intervention was effective but the results were of borderline significance Two large, high quality studies found no reduction in the rates of retained placenta compared with expectant management. This double-blind, placebo-controlled multicenter trial investigated the effectiveness of treatment with high-dose umbilical vein oxytocin in women with retained placenta. The study was conducted at teaching hospitals in the United Kingdom, Uganda, and Pakistan between 2004 and 2008. The participants were hemodynamically stable women who had a retained placenta for more than 30 minutes. A total of 577 women were randomly assigned to receive 30 ml saline containing either 50 IU oxytocin (n = 292) or 5 mL water (n = 285) via injection into the placenta through an umbilical vein catheter. The need for manual removal of the placenta was the primary outcome measure. No difference between the groups was found in the need for manual placental removal (oxytocin: 61.3% 179/292 vs. placebo: 62.1% 177/285 Relative Risk = 0.98, 95% confidence interval: 0.87–1.12; P = 0.84). There was a difference between the countries in the need for manual removal; the need was higher in the United Kingdom (69% 250/361) than in Uganda (47% 90/190); or Pakistan (62% 16/26). There was no difference in adverse events between the oxytocin and placebo groups. These findings are consistent with the results of other studies showing that umbilical injection of oxytocin has no clinically significant effect on the need for manual removal of the placenta in women with retained placenta, and suggest that other treatment approaches are necessary.