Intraumbilical Oxytocin Injection Investigated in Phase 3 Trial for Postpartum Hemorrhage Prevention

Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, especially in developing countries, complicating 3-5% of deliveries. Another critical complication is retained placenta, affecting 0.1-2% of deliveries, often requiring manual removal—a procedure demanding facilities frequently unavailable in resource-poor settings. Active management of the third stage of labor, including prophylactic 10 units of oxytocin intramuscularly, aims to reduce placental delivery time. However, limited data exist on the routine use of intraumbilical vein oxytocin, which could directly target the placental bed and uterine wall for earlier contraction and separation, addressing this critical gap.

This randomized, Phase 3 trial (NCT02319707) enrolled an estimated 500 pregnant women at 34-41 weeks of gestation to evaluate the beneficial effect of adding intraumbilical vein oxytocin. Participants were randomized into two groups: one receiving standard active management with 10 IU of IM Oxytocin, and a combined treatment group receiving 10 IU of IM Oxytocin plus an intraumbilical vein injection of oxytocin. The study aims to compare these two approaches during the third stage of labor to determine if the intraumbilical route improves outcomes related to postpartum hemorrhage and retained placenta.

The provided abstract describes the study's design and rationale but does not present any results or findings from the trial. Therefore, specific data points, statistical outcomes, or conclusions regarding the efficacy of intraumbilical oxytocin are not available in this record.