Prophylactic oxytocin in Uniject™ proposed to cut postpartum hemorrhage risk by 50% at Ghanaian home births

Globally, postpartum hemorrhage (PPH) remains a leading cause of maternal mortality, particularly in low-resource settings where access to skilled birth attendants and immediate medical care is limited. Home births, common in many regions like Ghana, often lack the infrastructure for timely PPH management. Prophylactic administration of uterotonic drugs, primarily oxytocin, is a cornerstone of active management of the third stage of labor to prevent PPH. However, challenges with cold chain storage, sterile administration, and trained personnel often hinder its widespread use in remote areas, creating a critical gap in maternal health interventions.

This Phase 3 clinical trial was designed to evaluate the efficacy of oxytocin 10 IU administered intramuscularly (IM) via the Uniject™ pre-filled syringe system. The intervention was to be given during the third stage of labor by Community Health Officers (CHOs) attending home births in Ghana. The study hypothesized that this intervention would reduce the risk of postpartum hemorrhage by 50 percent compared to a control group of home births attended by CHOs who did not provide any uterotonic drug. The primary endpoint was the incidence of PPH.

This study (NCT01710566) was officially withdrawn prior to enrollment, with an actual enrollment of 0 participants. Consequently, no data on the efficacy, safety, or any other outcomes related to the prophylactic administration of oxytocin 10 IU in Uniject™ for postpartum hemorrhage prevention at home births in Ghana were collected or reported. Therefore, no findings or results can be presented from this specific trial.